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PREconception Folic Acid Clinical Efficacy (PREFACE) Trial

ConditionsFolateFolate BioavailabilityClinical TrialsPregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age19-42
SponsorUniversity of British Columbia

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Currently trying to become pregnant;

Aged 19-42 years;

Low risk for an NTD-affected pregnancy

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Folic Acid

    Dietary supplement

    folic acid (0.6 mg)

  • 5-MTHF (5-methyltetrahydrofolate)

    Dietary supplement

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

Treatment groups

272 Participants
are divided into 2 treatment groups
Group A: 5MTHFExperimental treatment 1 intervention
Group B: Synthetic folic acidActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

RBC folate

•Maternal RBC folate concentrations (nmol/L)

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

Secondary outcomes

1

Maternal plasma placental growth factor (pg/mL)

A novel biomarker with increasing use in clinical practice due to a discriminatory capacity for fetal growth restriction vs a small, but healthy fetus

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

Other outcomes

1

Human milk total folate concentrations

Unmetabolized folic acid, reduced folate forms (nmol/L), and folate binding protein

Time frame
At 4 weeks postpartum

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of British Columbia

Lead sponsor

University of Saskatchewan

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: