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Methyl Folate for Folate Deficiency (FAB:ME Trial)
N/A
Waitlist Available
Research Sponsored by Oklahoma State University Center for Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
FAB:ME Trial Summary
This trial explores how folate supplementation affects mood, cognition, sleep, and overall health in young women. Results will inform public health practices.
Who is the study for?
This trial is for females aged 18-24 in the U.S. who have low dietary folate intake and are not on hormonal birth control. Participants must start the study one week after their menstrual cycle begins.Check my eligibility
What is being tested?
The study tests if taking Methyl Folate supplements affects blood folate levels, mood, cognition, and sleep patterns compared to a placebo (a pill with no active ingredients).See study design
What are the potential side effects?
Potential side effects of Methyl Folate may include unpleasant taste in the mouth, nausea, loss of appetite, confusion, irritability, sleep disturbances or feeling excited or irritable.
FAB:ME Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from day 14 serum folate status at day 15
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from day 14 serum folate status at day 15
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in cognition
Change in dietary folate consumption
Change in gastrointestinal symptoms
+5 moreFAB:ME Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Methyl FolateExperimental Treatment1 Intervention
Participants will receive a capsule containing 1,000 mcg methyl folate and microcrystalline cellulose orally once per day for 15 days.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a microcrystalline cellulose capsule orally once per day for 15 days.
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Who is running the clinical trial?
Oklahoma State University Center for Health SciencesLead Sponsor
35 Previous Clinical Trials
5,236 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You consume no more than 250 micrograms of DFEs from folate sources.You must commence the study precisely seven days after the onset of your menstrual cycle.I am a woman living in the United States.You are currently having your period.You are not utilizing hormonal contraception.You are currently taking a folate supplement.
Research Study Groups:
This trial has the following groups:- Group 1: Methyl Folate
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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