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Vitamin

(6S)-5-methyltetrahydrofolic acid for Pregnancy

N/A
Waitlist Available
Led By Crystal Karakochuk, PhD
Research Sponsored by University of British Columbia
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 (8-21 weeks gestation),and endline (24-37 weeks gestation)
Awards & highlights

Study Summary

This trial is testing whether folic acid or (6S)-5-methyltetrahydrofolic acid is more effective in supplementing pregnant women. 60 pregnant women will be given either 0.6mg/day of folic acid or 0.625mg/day of (6S)-5-methyltetrahydrofolic acid for 16 weeks to see which is more effective.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (8-21 weeks gestation),and endline (24-37 weeks gestation)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (8-21 weeks gestation),and endline (24-37 weeks gestation) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Concentration of red blood cell folate levels
Concentration of serum folate levels
Concentration of unmetabolized folic acid (and other folate forms: THF, 5-Methyl-THF, 5-formyl-THF, and 5,10-methenyl-THF)
Secondary outcome measures
Breastmilk fatty acids & choline forms (free choline, betaine, phosphocholine, glycerophosophocholine)
Breastmilk human milk oligosaccharides and breastmilk microbiome
Collection of peripheral blood mononuclear layer cells
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: (6S)-5-methyltetrahydrofolic acid (Metafolin)Experimental Treatment1 Intervention
0.625 mg/d (an equimolar dose to folic acid)
Group II: Folic acidActive Control1 Intervention
0.6 mg/day
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
(6S)-5-methyltetrahydrofolic acid
2019
N/A
~60

Find a Location

Who is running the clinical trial?

BC Children's Hospital Research InstituteOTHER
12 Previous Clinical Trials
2,282 Total Patients Enrolled
University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,466,956 Total Patients Enrolled
Crystal Karakochuk, PhDPrincipal InvestigatorUniversity of British Columbia
1 Previous Clinical Trials
208 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Natural Folate vs. Synthetic Folic Acid in Pregnancy
Crystal Karakochuk 2019. "Natural Folate vs. Synthetic Folic Acid in Pregnancy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04022135.
~11 spots leftby Apr 2025
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