PREconception Folic Acid Clinical Efficacy (PREFACE) Trial

University of British Columbia

Status: Not yet enrolling

Conditions: Folate Bioavailability; Folate; Clinical Trials; Pregnancy

Treatments: Dietary Supplement: Folic Acid; Dietary Supplement: 5-MTHF (5-methyltetrahydrofolate)

Study type: Interventional

Funder types: Other

Identifiers

NCT06641245

H24-01716

UBC CREB H24-01716 (Other Identifier)

Details and patient eligibility

About

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

Full 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).

Enrollment: 272 estimated patients

Sex: Female

Ages: 19 to 42 years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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272 participants in 2 patient groups

5MTHF

Experimental group

Description:

5MTHF

Treatment:

Dietary Supplement: 5-MTHF (5-methyltetrahydrofolate)

Synthetic folic acid

Active Comparator group

Description:

Folic acid

Treatment:

Dietary Supplement: Folic Acid