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Not yet recruiting NCT06641245

PREconception Folic Acid Clinical Efficacy (PREFACE) Trial

No phase Interventional Folate Folate Bioavailability Clinical Trials Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Folic Acid, 5-MTHF (5-methyltetrahydrofolate).
Who it may be relevant to
Registry conditions: Folate, Folate Bioavailability, Clinical Trials, Pregnancy. Basic parameters: 19 years — 42 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Dietary supplement Folic Acid
    folic acid (0.6 mg)
  • Dietary supplement 5-MTHF (5-methyltetrahydrofolate)
    0.625 mg/d (6S)-5-MTHF

Primary outcome measures

  • RBC folate [Time frame: At 6 (± 2) wks gestation (approximate time of neural tube closure)]
Secondary outcome measures (1)
  • Maternal plasma placental growth factor (pg/mL) [Time frame: At 18 (± 1) and 30 (± 1) wks gestation]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06641245 · H24-01716 · UBC CREB H24-01716

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗