PREconception Folic Acid Clinical Efficacy (PREFACE) Trial

Not Applicable

Not yet recruiting

• Conditions: Folate; Folate Bioavailability; Clinical Trials; Pregnancy

• Registration Number: NCT06641245
• Lead Sponsor: University of British Columbia

Brief 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).

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-11
• Study First Submitted QC: 2024-10-11
• Study First Posted: 2024-10-15
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Study Start: 2025-01-31
• Primary Completion: 2029-01-31
• Study Completion: 2030-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 272

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
RBC folate	At 6 (± 2) wks gestation (approximate time of neural tube closure)	•Maternal RBC folate concentrations (nmol/L)

Secondary Outcome Measures

Name	Time	Method
Maternal plasma placental growth factor (pg/mL)	At 18 (± 1) and 30 (± 1) wks gestation	A novel biomarker with increasing use in clinical practice due to a discriminatory capacity for fetal growth restriction vs a small, but healthy fetus