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Natural Folate vs. Synthetic Folic Acid in Pregnancy

NCT04022135 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-14

No results posted yet for this study

Summary

In this two-arm, double-blind randomized pilot study, the investigators will recruit 60 generally healthy, low-risk pregnant women aged 19-42 years living in Vancouver, Canada. Participants will be randomized to supplement with either 0.6 mg/day folic acid or an equimolar dose (0.625 mg/day) of (6S)-5-methyltetrahydrofolic acid for 16-weeks of their pregnancy. Randomization will occur at 8-21 weeks gestation (after neural tube closure) to reduce the risk of harm should the natural folate prove less effective. All participants will also receive a prenatal multivitamin not containing any form of folate, to ensure adequacy of other nutrients (e.g. iron) required during pregnancy. Three-hour fasting venous blood samples will be collected at baseline and endline to measure serum and red blood cell folate, unmetabolized folic acid and other related biomarkers. Women will be given the option to continue supplementing until 1-week postpartum, and provide a small (3mL) breastmilk sample and blood sample in order to measure differences in folates in breastmilk and postpartum folate. These pilot data will be used to inform a definitive trial regarding the most effective form of folate supplementation for mothers and their babies.

Conditions

  • Pregnancy

Interventions

DIETARY_SUPPLEMENT

Folic acid

Participants will supplement with 0.6mg/day for 16 weeks.

DIETARY_SUPPLEMENT

(6S)-5-methyltetrahydrofolic acid

Participants will supplement with 0.625mg/day for 16 weeks.

Sponsors & Collaborators

  • BC Children's Hospital Research Institute

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Crystal Karakochuk, PhD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-16
Primary Completion
2021-09-08
Completion
2021-09-08

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04022135 on ClinicalTrials.gov