PREconception Folic Acid Clinical Efficacy (PREFACE) Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-31

Study Completion Date

2030-01-31

Brief Summary

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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

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Detailed Description

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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).

Conditions

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Folate Folate Bioavailability Clinical Trials Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A double-blind randomized non-inferiority trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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5MTHF

Group Type EXPERIMENTAL

5-MTHF (5-methyltetrahydrofolate)

Intervention Type DIETARY_SUPPLEMENT

0.625 mg/d (6S)-5-MTHF

Synthetic folic acid

Folic acid

Group Type ACTIVE_COMPARATOR

Folic Acid

Intervention Type DIETARY_SUPPLEMENT

folic acid (0.6 mg)

Interventions

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Folic Acid

folic acid (0.6 mg)

Intervention Type DIETARY_SUPPLEMENT

5-MTHF (5-methyltetrahydrofolate)

0.625 mg/d (6S)-5-MTHF

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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).

Minimum Eligible Age

19 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No