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Relative Bioavailability of Folic Acid and L-5-Methlytetrahydrofolate

NCT01584050 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-08-10

No results posted yet for this study

Summary

Folic acid, a form of the vitamin folate, is added to grain products in Canada to help reduce birth defects. Folic acid is the synthetic form of folate and is very stable (doesn't break down) when added to foods. There are emerging health concerns about chronic folic acid consumption. Recently another more natural form of folate, L-5-methyltetrahydrofolate (L-MTHF) has become available. The investigators plan to conduct a randomized trial in women to determine if supplements containing L-MTHF consumed over three months raises blood folate levels as much as supplements containing folic acid. The investigators hypothesize that L-MTHF will increase red cell folate over 12 weeks to same extent as equimolar folic acid.

Conditions

  • Vitamin B12 Deficiency

Interventions

DIETARY_SUPPLEMENT

L-5-methyltetrahydrofolate (Metafolin ®)

dosage: 1000 μg, frequency: once daily, duration: 12 weeks

DIETARY_SUPPLEMENT

folic acid

dosage: 1000 μg, frequency: once daily, duration: 12 weeks

DIETARY_SUPPLEMENT

Placebo

frequency: once daily, duration: 12 weeks

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
42 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • Canada
  • Malaysia

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 NCT01584050 on ClinicalTrials.gov