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PREconception Folic Acid Clinical Efficacy (PREFACE) Trial | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

PREconception Folic Acid Clinical Efficacy (PREFACE) Trial

NCT06641245•University of British Columbia

Summary

A study to help understand what forms of folic acid are most effective to increase folate status during pregnancy for the best protection against neural tube defects

Detailed Description

A multisite randomized controlled trial to determine whether supplementation with (6S)-5-methyltetrahydrofolic acid (5-MTHF) is at least as effective as synthetic folic acid in increasing maternal folate status for protection against neural tube defects (NTDs).

Eligibility

Age

19 - 42 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Non-pregnant females who are:
•Currently trying to become pregnant;
•Aged 19-42 years;
•Low risk for an NTD-affected pregnancy

Exclusion Criteria

•Trying to conceive for ≥6 months (as \~90% of pregnancies occur after 6 months of trying);
•Diagnosed ovulatory disorders (polycystic ovary syndrome, endometriosis, or menstrual irregularity);
•More than 2 miscarriages in the past year;
•Undergoing fertility assistance (including current IVF or intrauterine insemination);
•Pre-existing medical condition known to impact maternal folate status (malabsorptive and inflammatory bowel diseases, active celiac disease, gastric bypass surgery, type 1 or 2 diabetes mellitus);
•Lifestyle factors known to impact maternal folate status (current smoking, \>6 alcoholic drinks per week, recreational drug use);
•On the female or male side of those trying to conceive: personal NTD history, previous NTD-affected pregnancy, or personal or family history of other folate sensitive congenital anomalies;
•Use of folate-inhibiting medications (Chloramphenicol, Methotrexate, Metformin, Sulfasalazine, Phenobarbital, Phenytoin, Primidone, Triamterene, Barbiturates).

Key Dates

Start Date

January 31, 2025

Primary Completion Date

January 31, 2029

Completion Date

January 31, 2030

Last Updated

October 21, 2024

Enrollment

272

ESTIMATED participants

Conditions

FolateFolate BioavailabilityClinical TrialsPregnancy

Interventions

Folic Acid

DIETARY_SUPPLEMENT

5-MTHF (5-methyltetrahydrofolate)

DIETARY_SUPPLEMENT

Contacts

Crystal D Karakochuk, PhD

CONTACT

604-822-0421 crystal.karakochuk@ubc.ca

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 21, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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PREconception Folic Acid Clinical Efficacy (PREFACE) Trial

Inclusion Criteria

Exclusion Criteria

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