Anemia, Iron DeficiencyNCT02404012
Iron Supplement to Improve Iron Status Following Bariatric Surgery
A study testing Oral iron supplementation in people with Anemia, Iron Deficiency, run by Indiana University at 1 site in United States.
Trial summary
There is a high prevalence of iron deficiency in patients who undergo bariatric surgery and effective therapies are lacking. Thus, there is a critical need for an effective, non-invasive, and inexpensive form of iron supplementation to treat iron deficiency and improve tolerance, the associated cognitive symptoms, and… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Anemia, Iron Deficiency
- What is being tested?
- Oral iron supplementation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a history of RYGB or SG weight loss surgery at least 6 months ago
- Subject meets at least 2 of the 4 previously mentioned conditions classifying them as iron deficient
- Subject is female
- Subject is at least 18 but not more than 65 years of age (post-menopausal status is an exclusion criteria)
- Subject has signed an informed consent.
Who cannot join
- Subject is pregnant
- Subject has history of surgical revision or conversion of bariatric procedure
- Subject is under a treatment regimen that requires iron supplementation greater than standard of care
- Subject has had parenteral iron less than one month before screening visit
- Subject has extremely heavy menstruation
- Subject has a history of hospitalization for acute illness in the previous 3 months
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- Subject has current active malignant neoplasm; or history of malignancy other than localized basal cell cancer of skin during previous 5 years
- Subject has gastrointestinal disease that involve increased inflammation or blood loss (e.g. Crohn's disease, Ulcerative colitis)
- Subject is post-menopausal
- Subject has severe anemia, with a hemoglobin > 7.0 g/dL (subjects will be notified of their results)
- Subject is taking an erythropoietin stimulating medication or is on hemodialysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Iron Supplement Formulations to Improve Iron Status Following Roux-en-Y and Sleeve Gastrectomy Bariatric Surgery
There is a high prevalence of iron deficiency in patients who undergo bariatric surgery and effective therapies are lacking. Thus, there is a critical need for an effective, non-invasive, and inexpensive form of iron supplementation to treat iron deficiency and improve tolerance, the associated cognitive symptoms, and quality of life in the bariatric surgery patient population. Often, patients do not participate in bariatric programs, are not compliant, and/or are lost to follow-up. If there is a more effective and evidence-based guideline for repletion of iron deficiency, patients are more likely to be compliant. Therefore, in a randomized controlled study, the investigators propose to test the effectiveness of various iron formulations versus ferrous sulfate, which is the standard of care, for oral iron supplementation of iron deficient patients who have had RYGB or SG bariatric surgery. By randomizing patients into the two groups, the investigators will be able to determine the most effective regimen to improve blood biomarkers of iron status, cognitive function, and quality of life. Other outcomes will include adverse effects and compliance to the supplementation. The investigators will also analyze three-day food records to determine the contribution of dietary factors to changes in iron status. To test for improvement of iron status, serial blood draws will be performed during a time period of ~10 weeks. Serial blood draws from iron deficient patients have routinely been performed in past studies and have not been found to be harmful. Because this is a relatively short study (10 weeks), subjects will be able to recover quickly from the blood loss during the study. The investigators expect to find that iron supplementation with organic formulations of iron will be as effective than ferrous sulfate for repletion of iron deficiency, and they will be better tolerated. This project will address a significant health issue in individuals who have had bariatric surgery, which is a growing population in the United States. It is estimated that almost 1.5 million individuals have undergone bariatric surgery since the year 1990.
Read the detailed description
Objectives:
- To determine the most effective oral iron supplementation regimen for repletion of iron deficiency in patients who have had gastric bypass or sleeve gastrectomy. In iron deficient patients, two supplement regimens will be compared:
- Ferrous sulfate 65 mg t.i.d. (standard of care / control), which is elemental iron
- AspironTM, which is an organic formulation of iron Primary outcomes will be reference indices of iron status:
- Ferritin, TIBC, sTfR, and sTfR:ferritin ratio
- Secondary outcomes will be:
- measures of anemia, determined by blood hemoglobin concentrations
- measures of cognitive function via several computerized tests on working memory, sustained attention, and spatial memory
- fatigue by Multidimensional Fatigue Inventory questionnaire
- Quality of life by SF-36 Survey Safety outcomes will be:
- adverse events, compliance, measures of iron toxicity, and liver enzymes
- In the same subjects undergoing iron supplementation described in Aim 1, to determine the contribution of dietary factors (including heme and non-heme iron intake, and intake of enhancers and inhibitors of iron absorption) to changes in iron status.
- Conditions
- Anemia, Iron Deficiency
- Being tested
- Oral iron supplementation
- Keywords
- iron deficiency, sleeve gastrectomy, gastric bypass, bariatric surgery
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral iron supplementationDietary supplement
Participants will be provided supplementation for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ferrous sulfate | Active comparator | Ferrous sulfate 65 mg. t.i.d is the standard of care for oral supplementation for iron deficiency Receives: Dietary Supplement: Oral iron supplementation |
| AspironTM 65 mg t.i.d. | Experimental | AspironTM, an organic formulation of iron, is the experimental treatment for oral supplementation of iron deficiency Receives: Dietary Supplement: Oral iron supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iron status
Ferritin, TIBC, sTfR
Measured: 8 weeks
Secondary outcomes (1)
Anemia assessed by Hemoglobin concentrations
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2019
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia, Iron DeficiencyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nana Gletsu Miller, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404012
- Sponsor's protocol ID
- IRB1410015305
- Status last verified
- Aug 2022
- First submitted
- 26 Mar 2015
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Iron Supplement Formulations to Improve Iron Status Following Roux-en-Y and Sleeve Gastrectomy Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02404012
- Acronym / sponsor ID
- IRB1410015305
- Conditions
- Anemia, Iron Deficiency
- Keywords
- iron deficiency, sleeve gastrectomy, gastric bypass, bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2019 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 31 Mar 2015 (estimated)
- 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.
There is a high prevalence of iron deficiency in patients who undergo bariatric surgery and effective therapies are lacking. Thus, there is a critical need for an effective, non-invasive, and inexpensive form of iron supplementation to treat iron deficiency and improve tolerance, the associated cognitive symptoms, and quality of life in the bariatric surgery patient population. Often, patients do not participate in bariatric programs, are not compliant, and/or are lost to follow-up. If there is a more effective and evidence-based guideline for repletion of iron deficiency, patients are more likely to be compliant. Therefore, in a randomized controlled study, the investigators propose to test the effectiveness of various iron formulations versus ferrous sulfate, which is the standard of care, for oral iron supplementation of iron deficient patients who have had RYGB or SG bariatric surgery. By randomizing patients into the two groups, the investigators will be able to determine the most effective regimen to improve blood biomarkers of iron status, cognitive function, and quality of life. Other outcomes will include adverse effects and compliance to the supplementation. The investigators will also analyze three-day food records to determine the contribution of dietary factors to changes in iron status. To test for improvement of iron status, serial blood draws will be performed during a time period of ~10 weeks. Serial blood draws from iron deficient patients have routinely been performed in past studies and have not been found to be harmful. Because this is a relatively short study (10 weeks), subjects will be able to recover quickly from the blood loss during the study. The investigators expect to find that iron supplementation with organic formulations of iron will be as effective than ferrous sulfate for repletion of iron deficiency, and they will be better tolerated. This project will address a significant health issue in individuals who have had bariatric surgery, which is a growing population in the United States. It is estimated that almost 1.5 million individuals have undergone bariatric surgery since the year 1990.
Detailed description
Objectives:
- To determine the most effective oral iron supplementation regimen for repletion of iron deficiency in patients who have had gastric bypass or sleeve gastrectomy. In iron deficient patients, two supplement regimens will be compared:
- Ferrous sulfate 65 mg t.i.d. (standard of care / control), which is elemental iron
- AspironTM, which is an organic formulation of iron Primary outcomes will be reference indices of iron status:
- Ferritin, TIBC, sTfR, and sTfR:ferritin ratio
- Secondary outcomes will be:
- measures of anemia, determined by blood hemoglobin concentrations
- measures of cognitive function via several computerized tests on working memory, sustained attention, and spatial memory
- fatigue by Multidimensional Fatigue Inventory questionnaire
- Quality of life by SF-36 Survey Safety outcomes will be:
- adverse events, compliance, measures of iron toxicity, and liver enzymes
- In the same subjects undergoing iron supplementation described in Aim 1, to determine the contribution of dietary factors (including heme and non-heme iron intake, and intake of enhancers and inhibitors of iron absorption) to changes in iron status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferrous sulfate | Active comparator | Dietary Supplement: Oral iron supplementationFerrous sulfate 65 mg. t.i.d is the standard of care for oral supplementation for iron deficiency |
| AspironTM 65 mg t.i.d. | Experimental | Dietary Supplement: Oral iron supplementationAspironTM, an organic formulation of iron, is the experimental treatment for oral supplementation of iron deficiency |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has a history of RYGB or SG weight loss surgery at least 6 months ago
- Subject meets at least 2 of the 4 previously mentioned conditions classifying them as iron deficient
- Subject is female
- Subject is at least 18 but not more than 65 years of age (post-menopausal status is an exclusion criteria)
- Subject has signed an informed consent.
Key exclusion criteria (11 listed)
- Subject is pregnant
- Subject has history of surgical revision or conversion of bariatric procedure
- Subject is under a treatment regimen that requires iron supplementation greater than standard of care
- Subject has had parenteral iron less than one month before screening visit
- Subject has extremely heavy menstruation
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 |
|---|---|---|
| Oral iron supplementationParticipants will be provided supplementation for 8 weeks | Dietary supplement | AspironTM 65 mg t.i.d., Ferrous sulfate |
Primary outcome
Iron status
Time frame: 8 weeks
Ferritin, TIBC, sTfR
1 secondary outcome
Anemia assessed by Hemoglobin concentrations
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral iron supplementation in people with Anemia, Iron Deficiency, run by Indiana 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 5 inclusion and 11 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: finished, as of the sponsor's last update on 5 Aug 2022. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Iron status (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2022.