Folate DeficiencyFAB:MENCT04095052
Food and Alcohol Behavior Study: Meaningful Enhancement
A study testing Methyl Folate in people with Folate Deficiency, run by Oklahoma State University Center for Health Sciences at 1 site in United States.
Trial summary
This study will determine how folate supplementation affects both serum and red blood cell folate status in females ages 18 -24 years old. Additionally, this study will determine the effect of folate supplementation on mood, cognition, and sleep patterns. Read more about this study
- Who is it for?
- Ages 18 to 24 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Folate Deficiency
- What is being tested?
- Methyl Folate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2019to 14 Aug 2024
- 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 24 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females restricted to those living in the United States
- Not currently using hormonal birth control
- Must experience menses
- Must begin the study exactly one week after the start of their menstrual cycle
- Folate consumption must be less than or equal to 250 micrograms of dietary folate equivalents (DFEs)
Who cannot join
- Current use of a folate supplement
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma State University Center for Health Sciences
Tulsa, Oklahoma, 74107
About this study
This study will determine how folate supplementation affects both serum and red blood cell folate status in females ages 18 -24 years old. Additionally, this study will determine the effect of folate supplementation on mood, cognition, and sleep patterns. This study will fill a crucial gap in understanding how folate status affects a variety of health behaviors in order to better inform public health practice and prevention.
Read the detailed description
Preliminary studies conducted by the investigator's team indicate that 95.7% of previous participants (all alcohol consuming, ages 14-24), were below the threshold for red blood cell (RBC) folate status for women of childbearing potential. Understanding how the interaction of behaviors (alcohol use, nutrient supplementation, diet) contribute to sub-optimal folate status is critical to developing and expanding upon evidence-based FASD prevention programs. Notably, how nutrient supplementation might improve overall folate status in a group with poor folate status and other behaviors that confound the absorption of folate. Because the participants do not view themselves as being at risk for unwanted pregnancy, their motivation to take a supplement for a future pregnancy is very low. This team seeks to collect data on how folate supplementation might improve individually measured outcomes, like cognition and mood, so that interventions might be developed focusing on these individual outcomes.
After becoming aware of the study, prospective participants will undergo a screening questionnaire for inclusion/exclusion criteria. Once the participant meets the inclusion criteria, the study will be fully explained and written informed consent will be handed out. Participants will be randomized in a single-blind manner (participant) in a 1:1 ratio to the Methyl Folate supplement (1,000 mcg, once daily) or placebo (once daily).
- Conditions
- Folate Deficiency
- Being tested
- Methyl Folate, Placebo
- Medical subject headings
- Folic Acid Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methyl FolateDietary supplement
1,000 mcg methyl folate and Microcrystalline Cellulose in a capsule
PlaceboDietary supplement
Microcrystalline Cellulose capsule
| Study group | Role | What they receive |
|---|---|---|
| Methyl Folate | Experimental | Participants will receive a capsule containing 1,000 mcg methyl folate and microcrystalline cellulose orally once per day for 15 days. Receives: Dietary Supplement: Methyl Folate |
| Placebo | Placebo comparator | Participants will receive a microcrystalline cellulose capsule orally once per day for 15 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Red blood cell folate status
Red blood cell folate status will be analyzed through dried blood spot samples collected on Arrayit blood cards, which use linear flow chromatography to separate whole blood into erythrocyte and serum. Red blood cell folate values represent a longer-term reduction in folate consumption or increases in folate excretion. Overturn of red blood cells occurs every 4 months, therefore, red blood cell folate status will only be assessed at baseline. The WHO-recommended cutoff of <340 nmol/L will be used to assess low red blood cell folate status.
Measured: Baseline
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from baseline serum folate status at day 1
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from day 1 serum folate status at day 2
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from day 2 serum folate status at day 3
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from day 3 serum folate status at day 4
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from day 4 serum folate status at day 5
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from day 5 serum folate status at day 6
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from day 6 serum folate status at day 7
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from day 7 serum folate status at day 8
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from day 8 serum folate status at day 9
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from day 9 serum folate status at day 10
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from day 10 serum folate status at day 11
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from day 11 serum folate status at day 12
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from day 12 serum folate status at day 13
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from day 13 serum folate status at day 14
Change in serum folate status
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Measured: Change from day 14 serum folate status at day 15
Change in gastrointestinal symptoms
Gastrointestinal health symptoms will be assessed by a short questionnaire aimed at capturing side-effects commonly associated with oral supplementation such as nausea, vomiting, heartburn, abdominal pain, diarrhea, and constipation.
Measured: Change from baseline gastrointestinal health status at day 7
Change in gastrointestinal symptoms
Gastrointestinal health symptoms will be assessed by a short questionnaire aimed at capturing side-effects commonly associated with oral supplementation such as nausea, vomiting, heartburn, abdominal pain, diarrhea, and constipation.
Measured: Change from day 7 gastrointestinal health status at day 15
Change in dietary folate consumption
The Block Dietary Folate Equivalents (DFE) Screener: A 21-item measure validated specifically for folate. This screener measures folate intake within a 1-week time period and will be assessed throughout the study period. DFE results are given as an calculated average of micro-grams per day. DFE's above 400 micro-grams meet the RDA for the study population.
Measured: Change from baseline dietary folate consumption at day 7
Change in dietary folate consumption
The Block Dietary Folate Equivalents (DFE) Screener: A 21-item measure validated specifically for folate. This screener measures folate intake within a 1-week time period and will be assessed throughout the study period. DFE results are given as an calculated average of micro-grams per day. DFE's above 400 micro-grams meet the RDA for the study population.
Measured: Change from day 7 dietary folate consumption at day 15
Change in mood
The Patient Health Questionnaire (PHQ-9): 9-item self-report screening tool used to assess and identify symptoms related to depression. The PHQ-9 has potential scores of 0-27 with scores of 5, 10, 15, and 20 representing thresholds for mild, moderate, moderately severe, and severe depression, respectively.
Positive and Negative Affect Schedule (PANAS-SF): 20-item self-report screening tool used to assess both positive and negative affect. Scores can range from 10-50, with higher scores representing higher levels of positive affect. Scores can range from 10-50, with lower scores representing lower levels of negative affect.
Brief Mood Introspection Scale (BMIS): 16-adjective scale to assess pleasant-unpleasant mood (scale range of 16-64), arousal-calm mood (scale range of 12-48), positive-tired mood (scale range of 7-28), and negative-relaxed mood (scale range of 6-24). Adding up the scored items reveals where an individual lies on each of the 4 subscales.
Measured: Change from baseline mood at day 7
Change in mood
The Patient Health Questionnaire (PHQ-9): 9-item self-report screening tool used to assess and identify symptoms related to depression. The PHQ-9 has potential scores of 0-27 with scores of 5, 10, 15, and 20 representing thresholds for mild, moderate, moderately severe, and severe depression, respectively.
Positive and Negative Affect Schedule (PANAS-SF): 20-item self-report screening tool used to assess both positive and negative affect. Scores can range from 10-50, with higher scores representing higher levels of positive affect. Scores can range from 10-50, with lower scores representing lower levels of negative affect.
Brief Mood Introspection Scale (BMIS): 16-adjective scale to assess pleasant-unpleasant mood (scale range of 16-64), arousal-calm mood (scale range of 12-48), positive-tired mood (scale range of 7-28), and negative-relaxed mood (scale range of 6-24). Adding up the scored items reveals where an individual lies on each of the 4 subscales.
Measured: Change from day 7 mood at day 15
Change in cognition
The NIH Toolbox Cognition Battery assesses cognitive functioning. Cognitive reports include several calculated scores including Age-Corrected Standard Scores, Uncorrected Standard Scores, and Fully Corrected T-Scores. The higher the score on each cognitive test, the higher the cognitive functioning.
Measured: Change from baseline cognitive functioning at day 7
Change in cognition
The NIH Toolbox Cognition Battery assesses cognitive functioning. Cognitive reports include several calculated scores including Age-Corrected Standard Scores, Uncorrected Standard Scores, and Fully Corrected T-Scores. The higher the score on each cognitive test, the higher the cognitive functioning.
Measured: Change from day 7 cognitive functioning at day 15
Change in sleep patterns
The Oura Ring is a wellness tracker used to track an individual's nightly sleep cycle and physical activity 24 hours per day. All data is synced via a smartphone application.
Measured: Change from baseline sleep patterns at day 7
Change in sleep patterns
The Oura Ring is a wellness tracker used to track an individual's nightly sleep cycle and physical activity 24 hours per day. All data is synced via a smartphone application.
Measured: Change from day 7 sleep patterns at day 15
Change in hair, nails, and skin satisfaction
A 6 item self-report screening tool for assessing satisfaction of hair, nails, and skin. Scores can range from 0-6. Results are recorded using a likert scale and will indicate changes in physical attribute satisfaction as supplementation occurs. A higher score represents a greater satisfaction whereas a lower score represents a lower satisfaction.
Measured: Change from baseline hair, nails, and skin satisfaction at day 7
Change in hair, nails, and skin satisfaction
A 6 item self-report screening tool for assessing satisfaction of hair, nails, and skin. Scores can range from 0-6. Results are recorded using a likert scale and will indicate changes in physical attribute satisfaction as supplementation occurs. A higher score represents a greater satisfaction whereas a lower score represents a lower satisfaction.
Measured: Change from day 7 hair, nails, and skin satisfaction at day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start14 Aug 2019
- Primary completion14 Aug 2023
- Study completion14 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Folate DeficiencyStudies 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 randomly assigned to a condition that receives a vitamin supplement (methyl folate), or a placebo group. Both the condition and placebo group will receive the same size pill once daily for 15 days and the pills will look the same. The condition group will receive a gel capsule containing the methyl folate supplement and a microcrystalline cellulose fiber. The placebo group will receive the same size gel capsule containing only the microcrystalline cellulose filler. The methyl folate supplement is the upper tolerable limit set by the Institute of Medicine. Taking more that the upper limit of 1000 mcg of methyl folate may be harmful; for this reason, it is important to discontinue vitamin use while enrolled in the study. Participants assigned to both the condition and placebo groups will be directly observed taking the pill during each daily appointment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oklahoma State University Center for Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Croff, Oklahoma State University Center for Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095052
- Sponsor's protocol ID
- 2022001
- Acronym
- FAB:ME
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2019
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food and Alcohol Behavior Study: Meaningful Enhancement
- ClinicalTrials.gov ID
- NCT04095052
- Acronym / sponsor ID
- FAB:ME / 2022001
- Conditions
- Folate Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Oklahoma State University Center for Health SciencesUniversity, hospital or other
- Study start
- 14 Aug 2019 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2024 (estimated)
- First posted
- 19 Sep 2019 (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.
This study will determine how folate supplementation affects both serum and red blood cell folate status in females ages 18 -24 years old. Additionally, this study will determine the effect of folate supplementation on mood, cognition, and sleep patterns. This study will fill a crucial gap in understanding how folate status affects a variety of health behaviors in order to better inform public health practice and prevention.
Detailed description
Preliminary studies conducted by the investigator's team indicate that 95.7% of previous participants (all alcohol consuming, ages 14-24), were below the threshold for red blood cell (RBC) folate status for women of childbearing potential. Understanding how the interaction of behaviors (alcohol use, nutrient supplementation, diet) contribute to sub-optimal folate status is critical to developing and expanding upon evidence-based FASD prevention programs. Notably, how nutrient supplementation might improve overall folate status in a group with poor folate status and other behaviors that confound the absorption of folate. Because the participants do not view themselves as being at risk for unwanted pregnancy, their motivation to take a supplement for a future pregnancy is very low. This team seeks to collect data on how folate supplementation might improve individually measured outcomes, like cognition and mood, so that interventions might be developed focusing on these individual outcomes.
After becoming aware of the study, prospective participants will undergo a screening questionnaire for inclusion/exclusion criteria. Once the participant meets the inclusion criteria, the study will be fully explained and written informed consent will be handed out. Participants will be randomized in a single-blind manner (participant) in a 1:1 ratio to the Methyl Folate supplement (1,000 mcg, once daily) or placebo (once daily).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to a condition that receives a vitamin supplement (methyl folate), or a placebo group. Both the condition and placebo group will receive the same size pill once daily for 15 days and the pills will look the same. The condition group will receive a gel capsule containing the methyl folate supplement and a microcrystalline cellulose fiber. The placebo group will receive the same size gel capsule containing only the microcrystalline cellulose filler. The methyl folate supplement is the upper tolerable limit set by the Institute of Medicine. Taking more that the upper limit of 1000 mcg of methyl folate may be harmful; for this reason, it is important to discontinue vitamin use while enrolled in the study. Participants assigned to both the condition and placebo groups will be directly observed taking the pill during each daily appointment.
| Arm | Type | Receives |
|---|---|---|
| Methyl Folate | Experimental | Dietary Supplement: Methyl FolateParticipants will receive a capsule containing 1,000 mcg methyl folate and microcrystalline cellulose orally once per day for 15 days. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants will receive a microcrystalline cellulose capsule orally once per day for 15 days. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females restricted to those living in the United States
- Not currently using hormonal birth control
- Must experience menses
- Must begin the study exactly one week after the start of their menstrual cycle
- Folate consumption must be less than or equal to 250 micrograms of dietary folate equivalents (DFEs)
Key exclusion criteria (1 listed)
- Current use of a folate supplement
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 |
|---|---|---|
| Methyl Folate1,000 mcg methyl folate and Microcrystalline Cellulose in a capsule | Dietary supplement | Methyl Folate |
| PlaceboMicrocrystalline Cellulose capsule | Dietary supplement | Placebo |
Primary outcome
Red blood cell folate status
Time frame: Baseline
Red blood cell folate status will be analyzed through dried blood spot samples collected on Arrayit blood cards, which use linear flow chromatography to separate whole blood into erythrocyte and serum. Red blood cell folate values represent a longer-term reduction in folate consumption or increases in folate excretion. Overturn of red blood cells occurs every 4 months, therefore, red blood cell folate status will only be assessed at baseline. The WHO-recommended cutoff of <340 nmol/L will be used to assess low red blood cell folate status.
Change in serum folate status
Time frame: Change from baseline serum folate status at day 1
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in serum folate status
Time frame: Change from day 1 serum folate status at day 2
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in serum folate status
Time frame: Change from day 2 serum folate status at day 3
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in serum folate status
Time frame: Change from day 3 serum folate status at day 4
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in serum folate status
Time frame: Change from day 4 serum folate status at day 5
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in serum folate status
Time frame: Change from day 5 serum folate status at day 6
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in serum folate status
Time frame: Change from day 6 serum folate status at day 7
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in serum folate status
Time frame: Change from day 7 serum folate status at day 8
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in serum folate status
Time frame: Change from day 8 serum folate status at day 9
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in serum folate status
Time frame: Change from day 9 serum folate status at day 10
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in serum folate status
Time frame: Change from day 10 serum folate status at day 11
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in serum folate status
Time frame: Change from day 11 serum folate status at day 12
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in serum folate status
Time frame: Change from day 12 serum folate status at day 13
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in serum folate status
Time frame: Change from day 13 serum folate status at day 14
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in serum folate status
Time frame: Change from day 14 serum folate status at day 15
Serum folate values will be analyzed through dried blood spot samples collected on Arrayit blood cards daily, which use linear flow chromatography to separate whole blood into erythrocyte and serum. The WHO-recommended cutoff of <10 nmol/L will be used to assess low serum folate status. Results will be reported as a concentration with higher values indicating improved serum folate status.
Change in gastrointestinal symptoms
Time frame: Change from baseline gastrointestinal health status at day 7
Gastrointestinal health symptoms will be assessed by a short questionnaire aimed at capturing side-effects commonly associated with oral supplementation such as nausea, vomiting, heartburn, abdominal pain, diarrhea, and constipation.
Change in gastrointestinal symptoms
Time frame: Change from day 7 gastrointestinal health status at day 15
Gastrointestinal health symptoms will be assessed by a short questionnaire aimed at capturing side-effects commonly associated with oral supplementation such as nausea, vomiting, heartburn, abdominal pain, diarrhea, and constipation.
Change in dietary folate consumption
Time frame: Change from baseline dietary folate consumption at day 7
The Block Dietary Folate Equivalents (DFE) Screener: A 21-item measure validated specifically for folate. This screener measures folate intake within a 1-week time period and will be assessed throughout the study period. DFE results are given as an calculated average of micro-grams per day. DFE's above 400 micro-grams meet the RDA for the study population.
Change in dietary folate consumption
Time frame: Change from day 7 dietary folate consumption at day 15
The Block Dietary Folate Equivalents (DFE) Screener: A 21-item measure validated specifically for folate. This screener measures folate intake within a 1-week time period and will be assessed throughout the study period. DFE results are given as an calculated average of micro-grams per day. DFE's above 400 micro-grams meet the RDA for the study population.
Change in mood
Time frame: Change from baseline mood at day 7
The Patient Health Questionnaire (PHQ-9): 9-item self-report screening tool used to assess and identify symptoms related to depression. The PHQ-9 has potential scores of 0-27 with scores of 5, 10, 15, and 20 representing thresholds for mild, moderate, moderately severe, and severe depression, respectively. Positive and Negative Affect Schedule (PANAS-SF): 20-item self-report screening tool used to assess both positive and negative affect. Scores can range from 10-50, with higher scores representing higher levels of positive affect. Scores can range from 10-50, with lower scores representing lower levels of negative affect. Brief Mood Introspection Scale (BMIS): 16-adjective scale to assess pleasant-unpleasant mood (scale range of 16-64), arousal-calm mood (scale range of 12-48), positive-tired mood (scale range of 7-28), and negative-relaxed mood (scale range of 6-24). Adding up the scored items reveals where an individual lies on each of the 4 subscales.
Change in mood
Time frame: Change from day 7 mood at day 15
The Patient Health Questionnaire (PHQ-9): 9-item self-report screening tool used to assess and identify symptoms related to depression. The PHQ-9 has potential scores of 0-27 with scores of 5, 10, 15, and 20 representing thresholds for mild, moderate, moderately severe, and severe depression, respectively. Positive and Negative Affect Schedule (PANAS-SF): 20-item self-report screening tool used to assess both positive and negative affect. Scores can range from 10-50, with higher scores representing higher levels of positive affect. Scores can range from 10-50, with lower scores representing lower levels of negative affect. Brief Mood Introspection Scale (BMIS): 16-adjective scale to assess pleasant-unpleasant mood (scale range of 16-64), arousal-calm mood (scale range of 12-48), positive-tired mood (scale range of 7-28), and negative-relaxed mood (scale range of 6-24). Adding up the scored items reveals where an individual lies on each of the 4 subscales.
Change in cognition
Time frame: Change from baseline cognitive functioning at day 7
The NIH Toolbox Cognition Battery assesses cognitive functioning. Cognitive reports include several calculated scores including Age-Corrected Standard Scores, Uncorrected Standard Scores, and Fully Corrected T-Scores. The higher the score on each cognitive test, the higher the cognitive functioning.
Change in cognition
Time frame: Change from day 7 cognitive functioning at day 15
The NIH Toolbox Cognition Battery assesses cognitive functioning. Cognitive reports include several calculated scores including Age-Corrected Standard Scores, Uncorrected Standard Scores, and Fully Corrected T-Scores. The higher the score on each cognitive test, the higher the cognitive functioning.
Change in sleep patterns
Time frame: Change from baseline sleep patterns at day 7
The Oura Ring is a wellness tracker used to track an individual's nightly sleep cycle and physical activity 24 hours per day. All data is synced via a smartphone application.
Change in sleep patterns
Time frame: Change from day 7 sleep patterns at day 15
The Oura Ring is a wellness tracker used to track an individual's nightly sleep cycle and physical activity 24 hours per day. All data is synced via a smartphone application.
Change in hair, nails, and skin satisfaction
Time frame: Change from baseline hair, nails, and skin satisfaction at day 7
A 6 item self-report screening tool for assessing satisfaction of hair, nails, and skin. Scores can range from 0-6. Results are recorded using a likert scale and will indicate changes in physical attribute satisfaction as supplementation occurs. A higher score represents a greater satisfaction whereas a lower score represents a lower satisfaction.
Change in hair, nails, and skin satisfaction
Time frame: Change from day 7 hair, nails, and skin satisfaction at day 15
A 6 item self-report screening tool for assessing satisfaction of hair, nails, and skin. Scores can range from 0-6. Results are recorded using a likert scale and will indicate changes in physical attribute satisfaction as supplementation occurs. A higher score represents a greater satisfaction whereas a lower score represents a lower satisfaction.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Folate Deficiency
RecruitingPhase 3
Torvutatug Samrotecan Plus Bevacizumab as First-line Maintenance in Non-Homologous Recombination Deficiency (Non-HRD) Positive Advanced Epithelial Ovarian Cancer
Epithelial Ovarian Cancer
Active, not recruiting
Iron Absorption From IFA and MMS Supplements in Kenyan Women During the Second Trimester of Pregnancy
Pregnancy
Not yet recruitingObservational study
Non-Interventional Study of Ferretab® Comp. (Ferrous Fumarate + Folic Acid Prolonged-Release Capsules) Effects in Adult Patients With Iron Deficiency Anemia and Cardiovascular Disease
Iron Deficiency Anemia, Coronary Artery Disease
Not yet recruiting
MMS, IFA, and MMS+IFA Supplementation in Pregnant Women
Maternal Anemia, Micronutrient Deficiency
Recruiting
Folic Acid Salt Study (FISFA Zambia)
Folate Deficiency, Neural Tube Defects
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 Methyl Folate in people with Folate Deficiency, run by Oklahoma State University Center for Health Sciences 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 1 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: status not confirmed, as of the sponsor's last update on 16 Aug 2023. 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?
Results are not available in the source record.
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?
Red blood cell folate status (time frame: Baseline). The study lists 28 primary outcomes in all. 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 16 Aug 2023.