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Bioavailability of Folic Acid Fortified Bread

NCT01570088 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2014-12-16

No results posted yet for this study

Summary

Folic acid is the synthetic form of vitamin folate. Because of its high stability and bioavailability, it is the form of folate added to bread in Canada to reduce birth defects. There are health concerns about long-term folic acid consumption. Another form of folate, L-5-methyltetrahydrofolic acid (L-5-MTHF) has become available which does not have these health concerns. Unfortunately L-5-MTHF is not as stable as folic acid, but the investigators have developed a method to stabilize L-5-MTHF in food. The investigators plan to conduct a randomized trial to compare the bioavailability of bread fortified with L-5-MTHF versus folic acid.

The investigators hypothesize that bread fortified with L-5-MTHF will increase red cell folate over 16 weeks to the same extent as bread fortified with equimolar folic acid.

Conditions

  • Red Blood Cell Folate

Interventions

DIETARY_SUPPLEMENT

Folic acid

One roll/bun per day fortified with 400 µg of folic acid

DIETARY_SUPPLEMENT

L-5-MTHF

One roll/bun per day fortified with 452 µg of L-5-MTHF

OTHER

Placebo

Placebo contains no folic acids

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Tim Green, PhD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-12-31
Completion
2012-12-31

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 NCT01570088 on ClinicalTrials.gov