Iron Deficiency Anemia TreatmentMENONCT06798584
How Does Perimenopausal Menorrhagia Affect Women's Quality of Life and Cognitive Function?
A study testing FeoSol Original Iron Supplement Tablets and 21st Century Gelatin Capsules in people with Iron Deficiency Anemia Treatment and Iron Deficiency, run by Purdue University at 1 site in United States.
Trial summary
The goal of this clinical trial is to investigate how iron status and heavy bleeding during the menopausal transition affect women's cognitive function and quality of life. The main questions it aims to answer are: What is the association between iron status, cognitive function, mood, quality of family relationships… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Iron Deficiency Anemia Treatment, Iron Deficiency, Iron Deficiency (Without Anemia)
- What is being tested?
- FeoSol Original Iron Supplement Tablets and 21st Century Gelatin Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Undergoing natural perimenopause
- English-speaking
- In general good health as documented by each woman's personal report that the participant is without any past history of a chronic health condition
Who cannot join
- Taking psychoactive drugs
- A history of hematological disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stone Hall
West Lafayette, Indiana, 47907
Laura E Murray-Kolb, PhD, 765-496-3570, lmurrayk@purdue.edu
Mun S Choi, MS, 765-496-6055, mchoi@purdue.edu
About this study
Official title: Rough Journey to Menopause: How Does Perimenopausal Menorrhagia Affect Women's Quality of Life and Cognitive Function?
The goal of this clinical trial is to investigate how iron status and heavy bleeding during the menopausal transition affect women's cognitive function and quality of life. The main questions it aims to answer are:
- What is the association between iron status, cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women?
- How does iron repletion, via supplementation, affect cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women?
Read more
The investigators will compare the effect of iron supplements to a placebo (gelatin capsule) to see if iron supplements could improve iron status, cognitive function, mood, quality of family relationships, and quality of life of iron-deficient and/or anemic women undergoing the menopausal transition.
Each participant will:
- Make 2 visits (about 2 hours each - baseline and endline) to the Clinical Research Center at Purdue
- Make a very brief visit at midpoint (about 10 minutes) for a checkup
- Take a daily study supplement or placebo for 4 months
Read the detailed description
(i) Recruitment: The investigators will recruit participants through advertisements and referrals. The investigators will utilize advertisements in Purdue Today, women's health clinics located in West Lafayette, Lafayette, and Indianapolis, and other social media platforms. Inclusion criteria are: all participants are undergoing natural perimenopause, English-speaking, and in general good health as documented by each woman's personal report that the participant is without any past history of a chronic health condition. The participants who have been using iron supplementation prior to the study may participate if the participants agree to discontinue the use of iron supplementation for the duration of the study. Lastly, individuals taking psychoactive drugs or with a history of hematological disorders will be excluded from the study.
(ii) Screening: Interested participants may either call or email the investigators using contact information found on the flyer or complete a short survey, which can be accessed via QR code on the flyer.
(iii) Randomization to treatment: Once the participants are classified as belonging to the IDA, ID, or IS groups, the participants will then be randomly assigned (within group) to receive either an iron supplement or a placebo for 4 months (previous studies have indicated a significant improvement in iron status and functional outcomes with a 4-month intervention period). FeoSol Original Iron Supplement Tablets (325 mg of ferrous sulfate containing 65 mg of elemental iron) will be used for the treatment (this have used this successfully in past studies) and 21st Century Gelatin Capsules (600 mg) will be used for the placebo (gelatin capsules have been used successfully for the placebo group, in past studies). Participants will be advised to take one capsule/tablet each day with food and store the given treatment out of the reach of children. Weekly phone calls or texts will be placed to each of the participants as a reminder to take supplements and to check tolerance to iron supplements. If intolerance to iron supplements are reported, participants may have an option to stop taking iron supplements. During weekly phone calls or texts, participants will also be asked if participants have started any new medications or become pregnant. If a participant becomes pregnant, participant's participation in the study will be terminated at that time. If a participant's physician is concerned about what the participants may be taking for this study, a participant's physician may contact either Mun Choi or Laura Murray-Kolb, whose contact information will be provided to all participants to share with physicians. Compliance will be measured through pill counts half-way through and at the end of the study. Group and treatment assignment will be blinded to the participants as well as the investigators.
(iv) Assessment of quality of life, mood, and family relationships: Assessment of these variables will take place before the blood draw at the Purdue Clinical Research Center at both baseline and endline of the study. Quality of life will be assessed using the self-administered MOS 36-Item Short Form Health Survey (SF-36) and the Menopause-Specific Quality of Life Questionnaire (MENQOL). These scales have been used extensively and shown to have good reliability with coefficients equal to or greater than 0.80 in most studies. For the assessment of mood, participants will be asked to complete the Beck Depression Inventory-II (BDI-II). The BDI-II is a 21-item self-reporting questionnaire and items will be summed to create a total score with higher scores indicating higher levels of depression. It has been widely used in research and clinical settings to measure depressive symptoms according to the diagnostic criteria listed in the Diagnostic and Statistical Manual for Mental Disorders. The BDI-II has been tested for validity and reliability in different populations and has good internal consistency and reliability. Family relationships will be assessed using the Family Adaptability and Cohesion Evaluation Scale IV Short Form (FACES-IV-SF). Ratio scores that are less than 1 indicate unbalanced families, or lower quality of interactions among family members. A recent validation study showed that the FACES-IV-SF demonstrated adequate reliability and good fit to the data as evidenced by the Cronbach's alphas for the subscales ranging from 0.63 (Enmeshment) to 0.93 (Satisfaction). All family members over the age of 12 (age of 13-17) that live with participants will be asked to complete this questionnaire. For family members who are under the age of 18, parental consent will be obtained when obtaining participant's written consent and youth assent will be obtained before the administration of the FACES-IV questionnaire via Qualtrics. For family members who are at or over the age of 18, individual consent will be obtained before the administration of the FACES-IV questionnaire via Qualtrics.
(v) Computerized measures of cognitive function: Executive function is an umbrella term that is used to describe complex mental operations such as planning, time perception, working memory, inhibition, self-monitoring and regulation, motor control, regulation of emotion, and motivation. To assess multiple domains of executive function in women with perimenopausal menorrhagia, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. The PEBL is a software package allowing the creation of computerized tests for experimental use and neuropsychological testing, and has been widely used in different populations to assess cognitive performance. Thus, the following tests will be performed through the PEBL to assess five domains of cognition in perimenopausal women in a lighting and temperature-controlled testing environment:
Berg Card Sorting Test: The short 64-card version of the Berg Card Sorting Test (BCST) will be used as one measure of executive function in women. The test entails sorting cards based on shape, color, or number. A participant is given feedback (correct or incorrect) after each sorting, and participant may need to adjust sorting strategy based on the feedback received. During the test, the sorting rule changes (unbeknownst to the participant) and when it does, a participant must adjust sorting strategy accordingly. The BCST is used to distinguish diminished mental capacity and the shortened 64-card version of the BCST has been validated for use.
Attention Network Task: The Attention Network Task (ANT) is designed to assess three components of executive attention in a 30-minute testing session. The three components of executive attention that the ANT assesses include alerting (the ability to perceive that there is something to be attentive to), orienting (the ability to direct and shift attention to where it is needed), and conflict (the ability to filter out competing information). This test will present a sequence of visual stimuli where a participant will be shown cues in the form of either one or two asterisks in order to predict an upcoming target presentation and/or to orient the target's location. The cue is then followed by the presentation of target arrows, which may appear individually or in an arrangement of five arrows. A participant will be asked to respond by indicating which way the central arrow is facing, and scores for each network of attention will be calculated by reaction time subtractions of different stimulus combinations. The ANT has been performed by different populations and has been validated for use.
Go/No-Go Task: The Go/No-Go (GNG) Task is designed to assess one's ability to inhibit impulsivity while responding to go cues. During the GNG task, a participant is presented with a 2 x 2 pattern with one star in each square. The participant is instructed to follow a sequential presentation of letters and respond to the target letter (P) by pressing a button on the keyboard as quickly as possible, while suppressing responses to the non-target letter (R). The sequential presentation of letters is randomly generated and presented for 500 milliseconds in one of four squares with a 1500-millisecond interstimulus interval.
Tower of London Task: The Tower of London (TOL) Task is designed to assess one's efficiency in planning. During the TOL task, a participant is provided with colored disks that can be placed in three stacks with a maximum height of 1, 2, or 3 disks. Participants need to match a target configuration by moving one disk at a time and trying to do so in as few moves as possible. Prior to the task, practice trials are provided, and participants will be instructed to plan their entire sequence of moves mentally before initiating. The outcomes of this task include excess moves, planning time, and total time.
Sternberg Memory Search Task: The Sternberg Memory Search (SMS) Task is designed to evaluate one's working memory. During the SMS task, a participant is required to remember a series of letters presented one at a time and is then probed about whether particular letters were part of the presented set. In addition to accuracy, the amount of transmitted information, or throughput, will be calculated to correct for chance level [throughput = {(uncorrected overall accuracy - 0.5) / 0.5} x the number of items included in the memory set].
- Being tested
- FeoSol Original Iron Supplement Tablets, 21st Century Gelatin Capsules
- Keywords
- Iron, Perimenopause, Iron Deficiency Anemia, Iron Deficiency, Cognitive Function, Quality of Life, Mood, Quality of Family Relationships, Menopause, Perimenopausal Menorrhagia, Abnormal Uterine Bleeding, Menopause Transition, Women's Health
- Medical subject headings
- Iron Deficiencies, Anemia, Iron-Deficiency, Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FeoSol Original Iron Supplement TabletsDietary supplement
325 mg of ferrous sulfate containing 65 mg of elemental iron
21st Century Gelatin CapsulesDietary supplement
600 mg
| Study group | Role | What they receive |
|---|---|---|
| Iron Sufficient - Placebo | Placebo comparator | Women classified as iron sufficient given a 4-month supply of gelatin capsules Receives: Dietary Supplement: 21st Century Gelatin Capsules |
| Iron Sufficient - Iron Supplements | Experimental | Women classified as iron sufficient given a 4-month supply of iron supplements Receives: Dietary Supplement: FeoSol Original Iron Supplement Tablets |
| Iron Deficient - Placebo | Placebo comparator | Women classified as iron deficient given a 4-month supply of gelatin capsules Receives: Dietary Supplement: 21st Century Gelatin Capsules |
| Iron Deficient - Iron Supplements | Experimental | Women classified as iron deficient given a 4-month supply of iron supplements Receives: Dietary Supplement: FeoSol Original Iron Supplement Tablets |
| Iron Deficient (Anemic) - Placebo | Placebo comparator | Women classified as anemic given a 4-month supply of gelatin capsules Receives: Dietary Supplement: 21st Century Gelatin Capsules |
| Iron Deficient (Anemic) - Iron Supplements | Experimental | Women classified as anemic given a 4-month supply of iron supplements Receives: Dietary Supplement: FeoSol Original Iron Supplement Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron Status Assessment
The investigators will measure plasma iron (mcg/dL).
Measured: From enrollment to the end of treatment at 4 months
Iron Status Assessment
The investigators will measure total iron binding capacity (TIBC) (mcg/dL).
Measured: From enrollment to the end of treatment at 4 months
Iron Status Assessment
The investigators will measure transferrin saturation (TSAT) (%).
Measured: From enrollment to the end of treatment at 4 months
Iron Status Assessment
The investigators will measure serum ferritin (Ft) (μg/L).
Measured: From enrollment to the end of treatment at 4 months
Iron Status Assessment
The investigators will measure serum transferrin receptor (TfR) (mg/L).
Measured: From enrollment to the end of treatment at 4 months
Iron Status Assessment
The investigators will measure CBC parameters (including hemoglobin (Hb) (g/dL), hematocrit (Hct) (%), mean corpuscular volume (MCV) (fL), and red blood cell distribution width (RDW) (fL)), which are measured in whole blood.
Measured: From enrollment to the end of treatment at 4 months
Iron Status Assessment
The investigators will measure serum hepcidin (ng/mL).
Measured: From enrollment to the end of treatment at 4 months
Iron Status Assessment
The investigators will calculate body Fe (mg/kg) using Cook's formula.
Measured: From enrollment to the end of treatment at 4 months
Inflammation Assessment
The investigators will measure α-1-acid glycoprotein (g/L) as an indicator of inflammation. In cases where inflammation is indicated, ferritin (μg/L) and TfR (mg/L) levels will not be used to assess iron status or concentrations will be adjusted using either the Thurnham or BRINDA methods.
Measured: From enrollment to the end of treatment at 4 months
Inflammation Assessment
The investigators will measure C-reactive protein (mg/L) as an indicator of inflammation. In cases where inflammation is indicated, ferritin (μg/L) and TfR (mg/L) levels will not be used to assess iron status or concentrations will be adjusted using either the Thurnham or BRINDA methods.
Measured: From enrollment to the end of treatment at 4 months
Cognitive Function Assessment
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Berg Card Sorting Test (# of categories completed and # of perseverative errors) will be performed through the PEBL to assess executive function in participants in a lighting and temperature-controlled testing environment.
Measured: From enrollment to the end of treatment at 4 months
Cognitive Function Assessment
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Attention Network Task (% correct for accuracy and reaction time, alerting, orienting, and conflict measurements in milliseconds) will be performed through the PEBL to assess alerting, orienting, and conflict in participants in a lighting and temperature-controlled testing environment.
Measured: From enrollment to the end of treatment at 4 months
Cognitive Function Assessment
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Go Task: The Go/No-Go (% correct for accuracy and reaction time in milliseconds) will be performed through the PEBL to assess the ability to inhibit impulsivity while responding to go cues in participants in a lighting and temperature-controlled testing environment.
Measured: From enrollment to the end of treatment at 4 months
Cognitive Function Assessment
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Tower of London Task (# of excess moves and planning and solution time in milliseconds) will be performed through the PEBL to assess the efficiency in planning in participants in a lighting and temperature-controlled testing environment.
Measured: From enrollment to the end of treatment at 4 months
Cognitive Function Assessment
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Sternberg Memory Search Task (% correct for accuracy, reaction time in milliseconds, and # of throughput) will be performed through the PEBL to assess working memory in participants in a lighting and temperature-controlled testing environment.
Measured: From enrollment to the end of treatment at 4 months
Quality of Life
Quality of life will be assessed using the self-administered MOS 36-Item Short Form Health Survey (SF-36), with a score ranging from 0 to 100, where higher scores indicate better health.
Measured: From enrollment to the end of treatment at 4 months
Quality of Life
Quality of life will be assessed using the Menopause-Specific Quality of Life Questionnaire (MENQOL), with a score ranging from 0 to 6, where higher scores indicate worse quality of life.
Measured: From enrollment to the end of treatment at 4 months
Assessment of Mood
Mood will be assessed using the Beck Depression Inventory-II (BDI-II) (with a score ranging from 0 to 63, where higher scores indicate worse depressive symptoms).
Measured: From enrollment to the end of treatment at 4 months
Assessment of Family Relationships
Family relationships will be assessed using the Family Adaptability and Cohesion Evaluation Scale IV Short Form (FACES-IV-SF) (with a score ranging from 0-1, where scores less than one represents families with problematic functioning).
Measured: From enrollment to the end of treatment at 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Mar 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency Anemia TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be classified as iron sufficient, iron deficient, or iron deficient anemic according to the following parameters. To be classified as iron deficient anemic (IDA): Hb between 100 and 119 g/L, and at least 2 of the following iron deficiency parameters: mean corpuscular volume (MCV) \< 80 fL, transferrin saturation (TSAT) \<15%, serum ferritin (Ft) \<15 ug/L, serum transferrin receptor \>8.3 mg/L, serum hepcidin \<8 ng/mL; to be classified as iron deficient without anemia (ID): at least 2 of the abnormal values listed above with a Hb\>=120 g/L; to be classified as iron sufficient (IS): Hb \>=120 g/L, MCV \>80 fL, TSAT \>15%, Ft \>20 ug/L, TfR \< 6 mg/L, and hepcidin \>8 ng/mL. Any participant with a Hb \<100 g/L will be excluded from the study as being too anemic and be referred to a physician for immediate treatment of the anemia. Any participant with a Ft\>200 ug/L will be excluded from the study and advised to follow up with a physician.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Purdue University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Murray Kolb, Purdue University
- Investigators
- Laura E Murray-Kolb, PhD, Principal investigator, Purdue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798584
- Sponsor's protocol ID
- IRB-2024-506
- Acronym
- MENO
- Status last verified
- Feb 2025
- First submitted
- 15 Nov 2024
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Whiteley J, DiBonaventura Md, Wagner JS, Alvir J, Shah S. The impact of menopausal symptoms on quality of life, productivity, and economic outcomes. J Womens Health (Larchmt). 2013 Nov;22(11):983-90. doi: 10.1089/jwh.2012.3719. Epub 2013 Oct 1.
PubMed 24083674Wenger MJ, Murray-Kolb LE, Nevins JE, Venkatramanan S, Reinhart GA, Wesley A, Haas JD. Consumption of a Double-Fortified Salt Affects Perceptual, Attentional, and Mnemonic Functioning in Women in a Randomized Controlled Trial in India. J Nutr. 2017 Dec;147(12):2297-2308. doi: 10.3945/jn.117.251587. Epub 2017 Oct 11.
PubMed 29021371Wenger MJ, Murray Kolb LE, Scott SP, Boy E, Haas JD. Modeling relationships between iron status, behavior, and brain electrophysiology: evidence from a randomized study involving a biofortified grain in Indian adolescents. BMC Public Health. 2022 Jul 6;22(1):1299. doi: 10.1186/s12889-022-13612-z.
PubMed 35794587Wenger MJ, DellaValle DM, Murray-Kolb LE, Haas JD. Effect of iron deficiency on simultaneous measures of behavior, brain activity, and energy expenditure in the performance of a cognitive task. Nutr Neurosci. 2019 Mar;22(3):196-206. doi: 10.1080/1028415X.2017.1360559. Epub 2017 Aug 7.
PubMed 28784049Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.
PubMed 24402217Thurnham DI, McCabe LD, Haldar S, Wieringa FT, Northrop-Clewes CA, McCabe GP. Adjusting plasma ferritin concentrations to remove the effects of subclinical inflammation in the assessment of iron deficiency: a meta-analysis. Am J Clin Nutr. 2010 Sep;92(3):546-55. doi: 10.3945/ajcn.2010.29284. Epub 2010 Jul 7.
PubMed 20610634Sydora BC, Fast H, Campbell S, Yuksel N, Lewis JE, Ross S. Use of the Menopause-Specific Quality of Life (MENQOL) questionnaire in research and clinical practice: a comprehensive scoping review. Menopause. 2016 Sep;23(9):1038-51. doi: 10.1097/GME.0000000000000636.
PubMed 27300115Sternberg S. High-speed scanning in human memory. Science. 1966 Aug 5;153(3736):652-4. doi: 10.1126/science.153.3736.652.
PubMed 5939936Schneider-Garces NJ, Gordon BA, Brumback-Peltz CR, Shin E, Lee Y, Sutton BP, Maclin EL, Gratton G, Fabiani M. Span, CRUNCH, and beyond: working memory capacity and the aging brain. J Cogn Neurosci. 2010 Apr;22(4):655-69. doi: 10.1162/jocn.2009.21230.
PubMed 19320550Shapley M, Blagojevic M, Jordan KP, Croft PR. The spontaneous resolution of heavy menstrual bleeding in the perimenopausal years. BJOG. 2012 Apr;119(5):545-53. doi: 10.1111/j.1471-0528.2012.03282.x. Epub 2012 Feb 8.
PubMed 22313942Scott SP, Murray-Kolb LE. Iron Status Is Associated with Performance on Executive Functioning Tasks in Nonanemic Young Women. J Nutr. 2016 Jan;146(1):30-7. doi: 10.3945/jn.115.223586. Epub 2015 Dec 9.
PubMed 26661838Santoro N. Perimenopause: From Research to Practice. J Womens Health (Larchmt). 2016 Apr;25(4):332-9. doi: 10.1089/jwh.2015.5556. Epub 2015 Dec 10.
PubMed 26653408Priest JB, Parker EO, Hiefner A, Woods SB, Roberson PNE. The Development and Validation of the FACES-IV-SF. J Marital Fam Ther. 2020 Oct;46(4):674-686. doi: 10.1111/jmft.12423. Epub 2020 Jan 31.
PubMed 32003487Namaste SM, Rohner F, Huang J, Bhushan NL, Flores-Ayala R, Kupka R, Mei Z, Rawat R, Williams AM, Raiten DJ, Northrop-Clewes CA, Suchdev PS. Adjusting ferritin concentrations for inflammation: Biomarkers Reflecting Inflammation and Nutritional Determinants of Anemia (BRINDA) project. Am J Clin Nutr. 2017 Jul;106(Suppl 1):359S-371S. doi: 10.3945/ajcn.116.141762. Epub 2017 Jun 14.
PubMed 28615259Murray-Kolb LE, Wenger MJ, Scott SP, Rhoten SE, Lung'aho MG, Haas JD. Consumption of Iron-Biofortified Beans Positively Affects Cognitive Performance in 18- to 27-Year-Old Rwandan Female College Students in an 18-Week Randomized Controlled Efficacy Trial. J Nutr. 2017 Nov;147(11):2109-2117. doi: 10.3945/jn.117.255356. Epub 2017 Sep 27.
PubMed 28954841
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rough Journey to Menopause: How Does Perimenopausal Menorrhagia Affect Women's Quality of Life and Cognitive Function?
- ClinicalTrials.gov ID
- NCT06798584
- Acronym / sponsor ID
- MENO / IRB-2024-506
- Keywords
- Iron, Perimenopause, Iron Deficiency Anemia, Iron Deficiency, Cognitive Function, Quality of Life, Mood, Quality of Family Relationships
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Purdue UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate how iron status and heavy bleeding during the menopausal transition affect women's cognitive function and quality of life. The main questions it aims to answer are:
- What is the association between iron status, cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women?
- How does iron repletion, via supplementation, affect cognitive function, mood, quality of family relationships, and quality of life in perimenopausal women?
The investigators will compare the effect of iron supplements to a placebo (gelatin capsule) to see if iron supplements could improve iron status, cognitive function, mood, quality of family relationships, and quality of life of iron-deficient and/or anemic women undergoing the menopausal transition.
Each participant will:
- Make 2 visits (about 2 hours each - baseline and endline) to the Clinical Research Center at Purdue
- Make a very brief visit at midpoint (about 10 minutes) for a checkup
- Take a daily study supplement or placebo for 4 months
Detailed description
(i) Recruitment: The investigators will recruit participants through advertisements and referrals. The investigators will utilize advertisements in Purdue Today, women's health clinics located in West Lafayette, Lafayette, and Indianapolis, and other social media platforms. Inclusion criteria are: all participants are undergoing natural perimenopause, English-speaking, and in general good health as documented by each woman's personal report that the participant is without any past history of a chronic health condition. The participants who have been using iron supplementation prior to the study may participate if the participants agree to discontinue the use of iron supplementation for the duration of the study. Lastly, individuals taking psychoactive drugs or with a history of hematological disorders will be excluded from the study.
(ii) Screening: Interested participants may either call or email the investigators using contact information found on the flyer or complete a short survey, which can be accessed via QR code on the flyer.
(iii) Randomization to treatment: Once the participants are classified as belonging to the IDA, ID, or IS groups, the participants will then be randomly assigned (within group) to receive either an iron supplement or a placebo for 4 months (previous studies have indicated a significant improvement in iron status and functional outcomes with a 4-month intervention period). FeoSol Original Iron Supplement Tablets (325 mg of ferrous sulfate containing 65 mg of elemental iron) will be used for the treatment (this have used this successfully in past studies) and 21st Century Gelatin Capsules (600 mg) will be used for the placebo (gelatin capsules have been used successfully for the placebo group, in past studies). Participants will be advised to take one capsule/tablet each day with food and store the given treatment out of the reach of children. Weekly phone calls or texts will be placed to each of the participants as a reminder to take supplements and to check tolerance to iron supplements. If intolerance to iron supplements are reported, participants may have an option to stop taking iron supplements. During weekly phone calls or texts, participants will also be asked if participants have started any new medications or become pregnant. If a participant becomes pregnant, participant's participation in the study will be terminated at that time. If a participant's physician is concerned about what the participants may be taking for this study, a participant's physician may contact either Mun Choi or Laura Murray-Kolb, whose contact information will be provided to all participants to share with physicians. Compliance will be measured through pill counts half-way through and at the end of the study. Group and treatment assignment will be blinded to the participants as well as the investigators.
(iv) Assessment of quality of life, mood, and family relationships: Assessment of these variables will take place before the blood draw at the Purdue Clinical Research Center at both baseline and endline of the study. Quality of life will be assessed using the self-administered MOS 36-Item Short Form Health Survey (SF-36) and the Menopause-Specific Quality of Life Questionnaire (MENQOL). These scales have been used extensively and shown to have good reliability with coefficients equal to or greater than 0.80 in most studies. For the assessment of mood, participants will be asked to complete the Beck Depression Inventory-II (BDI-II). The BDI-II is a 21-item self-reporting questionnaire and items will be summed to create a total score with higher scores indicating higher levels of depression. It has been widely used in research and clinical settings to measure depressive symptoms according to the diagnostic criteria listed in the Diagnostic and Statistical Manual for Mental Disorders. The BDI-II has been tested for validity and reliability in different populations and has good internal consistency and reliability. Family relationships will be assessed using the Family Adaptability and Cohesion Evaluation Scale IV Short Form (FACES-IV-SF). Ratio scores that are less than 1 indicate unbalanced families, or lower quality of interactions among family members. A recent validation study showed that the FACES-IV-SF demonstrated adequate reliability and good fit to the data as evidenced by the Cronbach's alphas for the subscales ranging from 0.63 (Enmeshment) to 0.93 (Satisfaction). All family members over the age of 12 (age of 13-17) that live with participants will be asked to complete this questionnaire. For family members who are under the age of 18, parental consent will be obtained when obtaining participant's written consent and youth assent will be obtained before the administration of the FACES-IV questionnaire via Qualtrics. For family members who are at or over the age of 18, individual consent will be obtained before the administration of the FACES-IV questionnaire via Qualtrics.
(v) Computerized measures of cognitive function: Executive function is an umbrella term that is used to describe complex mental operations such as planning, time perception, working memory, inhibition, self-monitoring and regulation, motor control, regulation of emotion, and motivation. To assess multiple domains of executive function in women with perimenopausal menorrhagia, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. The PEBL is a software package allowing the creation of computerized tests for experimental use and neuropsychological testing, and has been widely used in different populations to assess cognitive performance. Thus, the following tests will be performed through the PEBL to assess five domains of cognition in perimenopausal women in a lighting and temperature-controlled testing environment:
Berg Card Sorting Test: The short 64-card version of the Berg Card Sorting Test (BCST) will be used as one measure of executive function in women. The test entails sorting cards based on shape, color, or number. A participant is given feedback (correct or incorrect) after each sorting, and participant may need to adjust sorting strategy based on the feedback received. During the test, the sorting rule changes (unbeknownst to the participant) and when it does, a participant must adjust sorting strategy accordingly. The BCST is used to distinguish diminished mental capacity and the shortened 64-card version of the BCST has been validated for use.
Attention Network Task: The Attention Network Task (ANT) is designed to assess three components of executive attention in a 30-minute testing session. The three components of executive attention that the ANT assesses include alerting (the ability to perceive that there is something to be attentive to), orienting (the ability to direct and shift attention to where it is needed), and conflict (the ability to filter out competing information). This test will present a sequence of visual stimuli where a participant will be shown cues in the form of either one or two asterisks in order to predict an upcoming target presentation and/or to orient the target's location. The cue is then followed by the presentation of target arrows, which may appear individually or in an arrangement of five arrows. A participant will be asked to respond by indicating which way the central arrow is facing, and scores for each network of attention will be calculated by reaction time subtractions of different stimulus combinations. The ANT has been performed by different populations and has been validated for use.
Go/No-Go Task: The Go/No-Go (GNG) Task is designed to assess one's ability to inhibit impulsivity while responding to go cues. During the GNG task, a participant is presented with a 2 x 2 pattern with one star in each square. The participant is instructed to follow a sequential presentation of letters and respond to the target letter (P) by pressing a button on the keyboard as quickly as possible, while suppressing responses to the non-target letter (R). The sequential presentation of letters is randomly generated and presented for 500 milliseconds in one of four squares with a 1500-millisecond interstimulus interval.
Tower of London Task: The Tower of London (TOL) Task is designed to assess one's efficiency in planning. During the TOL task, a participant is provided with colored disks that can be placed in three stacks with a maximum height of 1, 2, or 3 disks. Participants need to match a target configuration by moving one disk at a time and trying to do so in as few moves as possible. Prior to the task, practice trials are provided, and participants will be instructed to plan their entire sequence of moves mentally before initiating. The outcomes of this task include excess moves, planning time, and total time.
Sternberg Memory Search Task: The Sternberg Memory Search (SMS) Task is designed to evaluate one's working memory. During the SMS task, a participant is required to remember a series of letters presented one at a time and is then probed about whether particular letters were part of the presented set. In addition to accuracy, the amount of transmitted information, or throughput, will be calculated to correct for chance level [throughput = {(uncorrected overall accuracy - 0.5) / 0.5} x the number of items included in the memory set].
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Participants will be classified as iron sufficient, iron deficient, or iron deficient anemic according to the following parameters. To be classified as iron deficient anemic (IDA): Hb between 100 and 119 g/L, and at least 2 of the following iron deficiency parameters: mean corpuscular volume (MCV) < 80 fL, transferrin saturation (TSAT) <15%, serum ferritin (Ft) <15 ug/L, serum transferrin receptor >8.3 mg/L, serum hepcidin <8 ng/mL; to be classified as iron deficient without anemia (ID): at least 2 of the abnormal values listed above with a Hb>=120 g/L; to be classified as iron sufficient (IS): Hb >=120 g/L, MCV >80 fL, TSAT >15%, Ft >20 ug/L, TfR < 6 mg/L, and hepcidin >8 ng/mL. Any participant with a Hb <100 g/L will be excluded from the study as being too anemic and be referred to a physician for immediate treatment of the anemia. Any participant with a Ft>200 ug/L will be excluded from the study and advised to follow up with a physician.
| Arm | Type | Receives |
|---|---|---|
| Iron Sufficient - Placebo | Placebo comparator | Dietary Supplement: 21st Century Gelatin CapsulesWomen classified as iron sufficient given a 4-month supply of gelatin capsules |
| Iron Sufficient - Iron Supplements | Experimental | Dietary Supplement: FeoSol Original Iron Supplement TabletsWomen classified as iron sufficient given a 4-month supply of iron supplements |
| Iron Deficient - Placebo | Placebo comparator | Dietary Supplement: 21st Century Gelatin CapsulesWomen classified as iron deficient given a 4-month supply of gelatin capsules |
| Iron Deficient - Iron Supplements | Experimental | Dietary Supplement: FeoSol Original Iron Supplement TabletsWomen classified as iron deficient given a 4-month supply of iron supplements |
| Iron Deficient (Anemic) - Placebo | Placebo comparator | Dietary Supplement: 21st Century Gelatin CapsulesWomen classified as anemic given a 4-month supply of gelatin capsules |
| Iron Deficient (Anemic) - Iron Supplements | Experimental | Dietary Supplement: FeoSol Original Iron Supplement TabletsWomen classified as anemic given a 4-month supply of iron supplements |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing natural perimenopause
- English-speaking
- In general good health as documented by each woman's personal report that the participant is without any past history of a chronic health condition
Key exclusion criteria (2 listed)
- Taking psychoactive drugs
- A history of hematological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FeoSol Original Iron Supplement Tablets325 mg of ferrous sulfate containing 65 mg of elemental iron | Dietary supplement | Iron Deficient (Anemic) - Iron Supplements, Iron Deficient - Iron Supplements, Iron Sufficient - Iron Supplements |
| 21st Century Gelatin Capsules600 mg | Dietary supplement | Iron Deficient (Anemic) - Placebo, Iron Deficient - Placebo, Iron Sufficient - Placebo |
Primary outcome
Iron Status Assessment
Time frame: From enrollment to the end of treatment at 4 months
The investigators will measure plasma iron (mcg/dL).
Iron Status Assessment
Time frame: From enrollment to the end of treatment at 4 months
The investigators will measure total iron binding capacity (TIBC) (mcg/dL).
Iron Status Assessment
Time frame: From enrollment to the end of treatment at 4 months
The investigators will measure transferrin saturation (TSAT) (%).
Iron Status Assessment
Time frame: From enrollment to the end of treatment at 4 months
The investigators will measure serum ferritin (Ft) (μg/L).
Iron Status Assessment
Time frame: From enrollment to the end of treatment at 4 months
The investigators will measure serum transferrin receptor (TfR) (mg/L).
Iron Status Assessment
Time frame: From enrollment to the end of treatment at 4 months
The investigators will measure CBC parameters (including hemoglobin (Hb) (g/dL), hematocrit (Hct) (%), mean corpuscular volume (MCV) (fL), and red blood cell distribution width (RDW) (fL)), which are measured in whole blood.
Iron Status Assessment
Time frame: From enrollment to the end of treatment at 4 months
The investigators will measure serum hepcidin (ng/mL).
Iron Status Assessment
Time frame: From enrollment to the end of treatment at 4 months
The investigators will calculate body Fe (mg/kg) using Cook's formula.
Inflammation Assessment
Time frame: From enrollment to the end of treatment at 4 months
The investigators will measure α-1-acid glycoprotein (g/L) as an indicator of inflammation. In cases where inflammation is indicated, ferritin (μg/L) and TfR (mg/L) levels will not be used to assess iron status or concentrations will be adjusted using either the Thurnham or BRINDA methods.
Inflammation Assessment
Time frame: From enrollment to the end of treatment at 4 months
The investigators will measure C-reactive protein (mg/L) as an indicator of inflammation. In cases where inflammation is indicated, ferritin (μg/L) and TfR (mg/L) levels will not be used to assess iron status or concentrations will be adjusted using either the Thurnham or BRINDA methods.
Cognitive Function Assessment
Time frame: From enrollment to the end of treatment at 4 months
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Berg Card Sorting Test (# of categories completed and # of perseverative errors) will be performed through the PEBL to assess executive function in participants in a lighting and temperature-controlled testing environment.
Cognitive Function Assessment
Time frame: From enrollment to the end of treatment at 4 months
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Attention Network Task (% correct for accuracy and reaction time, alerting, orienting, and conflict measurements in milliseconds) will be performed through the PEBL to assess alerting, orienting, and conflict in participants in a lighting and temperature-controlled testing environment.
Cognitive Function Assessment
Time frame: From enrollment to the end of treatment at 4 months
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Go Task: The Go/No-Go (% correct for accuracy and reaction time in milliseconds) will be performed through the PEBL to assess the ability to inhibit impulsivity while responding to go cues in participants in a lighting and temperature-controlled testing environment.
Cognitive Function Assessment
Time frame: From enrollment to the end of treatment at 4 months
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Tower of London Task (# of excess moves and planning and solution time in milliseconds) will be performed through the PEBL to assess the efficiency in planning in participants in a lighting and temperature-controlled testing environment.
Cognitive Function Assessment
Time frame: From enrollment to the end of treatment at 4 months
To assess multiple domains of executive function, the Psychology Experiment Building Language (PEBL) platform will be utilized to evaluate cognitive domains that were shown to be affected by iron status in previous studies. Sternberg Memory Search Task (% correct for accuracy, reaction time in milliseconds, and # of throughput) will be performed through the PEBL to assess working memory in participants in a lighting and temperature-controlled testing environment.
Quality of Life
Time frame: From enrollment to the end of treatment at 4 months
Quality of life will be assessed using the self-administered MOS 36-Item Short Form Health Survey (SF-36), with a score ranging from 0 to 100, where higher scores indicate better health.
Quality of Life
Time frame: From enrollment to the end of treatment at 4 months
Quality of life will be assessed using the Menopause-Specific Quality of Life Questionnaire (MENQOL), with a score ranging from 0 to 6, where higher scores indicate worse quality of life.
Assessment of Mood
Time frame: From enrollment to the end of treatment at 4 months
Mood will be assessed using the Beck Depression Inventory-II (BDI-II) (with a score ranging from 0 to 63, where higher scores indicate worse depressive symptoms).
Assessment of Family Relationships
Time frame: From enrollment to the end of treatment at 4 months
Family relationships will be assessed using the Family Adaptability and Cohesion Evaluation Scale IV Short Form (FACES-IV-SF) (with a score ranging from 0-1, where scores less than one represents families with problematic functioning).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Background: PubMed 24083674Whiteley J, DiBonaventura Md, Wagner JS, Alvir J, Shah S. The impact of menopausal symptoms on quality of life, productivity, and economic outcomes. J Womens Health (Larchmt). 2013 Nov;22(11):983-90. doi: 10.1089/jwh.2012.3719. Epub 2013 Oct 1.
- Background: PubMed 29021371Wenger MJ, Murray-Kolb LE, Nevins JE, Venkatramanan S, Reinhart GA, Wesley A, Haas JD. Consumption of a Double-Fortified Salt Affects Perceptual, Attentional, and Mnemonic Functioning in Women in a Randomized Controlled Trial in India. J Nutr. 2017 Dec;147(12):2297-2308. doi: 10.3945/jn.117.251587. Epub 2017 Oct 11.
- Background: PubMed 35794587Wenger MJ, Murray Kolb LE, Scott SP, Boy E, Haas JD. Modeling relationships between iron status, behavior, and brain electrophysiology: evidence from a randomized study involving a biofortified grain in Indian adolescents. BMC Public Health. 2022 Jul 6;22(1):1299. doi: 10.1186/s12889-022-13612-z.
- Background: PubMed 28784049Wenger MJ, DellaValle DM, Murray-Kolb LE, Haas JD. Effect of iron deficiency on simultaneous measures of behavior, brain activity, and energy expenditure in the performance of a cognitive task. Nutr Neurosci. 2019 Mar;22(3):196-206. doi: 10.1080/1028415X.2017.1360559. Epub 2017 Aug 7.
- Background: PubMed 24402217Wang YP, Gorenstein C. Psychometric properties of the Beck Depression Inventory-II: a comprehensive review. Braz J Psychiatry. 2013 Oct-Dec;35(4):416-31. doi: 10.1590/1516-4446-2012-1048. Epub 2013 Dec 23.
- Background: PubMed 20610634Thurnham DI, McCabe LD, Haldar S, Wieringa FT, Northrop-Clewes CA, McCabe GP. Adjusting plasma ferritin concentrations to remove the effects of subclinical inflammation in the assessment of iron deficiency: a meta-analysis. Am J Clin Nutr. 2010 Sep;92(3):546-55. doi: 10.3945/ajcn.2010.29284. Epub 2010 Jul 7.
- Background: PubMed 27300115Sydora BC, Fast H, Campbell S, Yuksel N, Lewis JE, Ross S. Use of the Menopause-Specific Quality of Life (MENQOL) questionnaire in research and clinical practice: a comprehensive scoping review. Menopause. 2016 Sep;23(9):1038-51. doi: 10.1097/GME.0000000000000636.
- Background: PubMed 5939936Sternberg S. High-speed scanning in human memory. Science. 1966 Aug 5;153(3736):652-4. doi: 10.1126/science.153.3736.652.
- Background: PubMed 19320550Schneider-Garces NJ, Gordon BA, Brumback-Peltz CR, Shin E, Lee Y, Sutton BP, Maclin EL, Gratton G, Fabiani M. Span, CRUNCH, and beyond: working memory capacity and the aging brain. J Cogn Neurosci. 2010 Apr;22(4):655-69. doi: 10.1162/jocn.2009.21230.
- Background: PubMed 22313942Shapley M, Blagojevic M, Jordan KP, Croft PR. The spontaneous resolution of heavy menstrual bleeding in the perimenopausal years. BJOG. 2012 Apr;119(5):545-53. doi: 10.1111/j.1471-0528.2012.03282.x. Epub 2012 Feb 8.
- Background: PubMed 26661838Scott SP, Murray-Kolb LE. Iron Status Is Associated with Performance on Executive Functioning Tasks in Nonanemic Young Women. J Nutr. 2016 Jan;146(1):30-7. doi: 10.3945/jn.115.223586. Epub 2015 Dec 9.
- Background: PubMed 26653408Santoro N. Perimenopause: From Research to Practice. J Womens Health (Larchmt). 2016 Apr;25(4):332-9. doi: 10.1089/jwh.2015.5556. Epub 2015 Dec 10.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laura E Murray-Kolb, PhD principal investigator
Purdue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FeoSol Original Iron Supplement Tablets and 21st Century Gelatin Capsules in people with Iron Deficiency Anemia Treatment and Iron Deficiency, run by Purdue University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura E Murray-Kolb, PhD (765-496-3570, lmurrayk@purdue.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron Status Assessment (time frame: From enrollment to the end of treatment at 4 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06798584, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.