PREconception Folic Acid Clinical Efficacy (PREFACE) Trial

NCT06641245 | Not Yet Recruiting

• 2 other identifiers: H24-01716UBC CREB H24-01716
• Study Type: interventional
• Target: 272
• Locations: 0 countries
• Sites: N/A

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

Conditions

Folate; Folate Bioavailability; Clinical Trials; Pregnancy

Keywords

Folic acid; Folate; Methylfolate; 5-MTHF; RBC Folate; Placental Growth Factor

Outcome Measures

Primary Outcomes (1)

• RBC folate

  •Maternal RBC folate concentrations (nmol/L)

  At 6 (± 2) wks gestation (approximate time of neural tube closure)

Secondary Outcomes (1)

• Maternal plasma placental growth factor (pg/mL)

  At 18 (± 1) and 30 (± 1) wks gestation

Other Outcomes (1)

• Human milk total folate concentrations

  At 4 weeks postpartum

Study Arms (2)

5MTHF

EXPERIMENTAL

5MTHF

Dietary Supplement: 5-MTHF (5-methyltetrahydrofolate)

Synthetic folic acid

ACTIVE COMPARATOR

Folic acid

Dietary Supplement: Folic Acid

Interventions

Folic Acid DIETARY_SUPPLEMENT

folic acid (0.6 mg)

Synthetic folic acid

5-MTHF (5-methyltetrahydrofolate) DIETARY_SUPPLEMENT

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

5MTHF

Eligibility Criteria

• Age: 19 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of British Columbia: lead
• University of Saskatchewan: collaborator

MeSH Terms

Interventions

Folic Acid; 5-methyltetrahydrofolate

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Crystal D Karakochuk, PhD

  The University of British Columbia

  PRINCIPAL INVESTIGATOR

• Kelsey M Cochrane, PhD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal D Karakochuk, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Human Nutrition

Model Details: A double-blind randomized non-inferiority trial

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: October 15, 2024
• Study Start: January 31, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2030
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share