Overview

This trial is active, not recruiting.

Condition red blood cell folate
Treatments folic acid, l-5-mthf, placebo
Phase phase 2
Sponsor University of British Columbia
Start date April 2012
End date December 2012
Trial size 90 participants
Trial identifier NCT01570088, H12-00339

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification bio-availability study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Arm
(Active Comparator)
folic acid
One roll/bun per day fortified with 400 µg of folic acid
(Experimental)
l-5-mthf
One roll/bun per day fortified with 452 µg of L-5-MTHF
(Placebo Comparator)
placebo
Placebo contains no folic acids

Primary Outcomes

Measure
red blood cell folate concentration at three time points
time frame: baseline, 8th week, 16th week

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

Inclusion Criteria: - 18-45 years - Not taking a folic acid containing supplement Exclusion Criteria: - Adults who have medical conditions such as diabetes, asthma, cancer, cardiovascular disease, high blood pressure, celiac disease, or psychiatric illness - Adults who are taking medications known to interfere with folate metabolism (i.e. phenytoin, sulphasalazine, methotrexate) - Adults with wheat, milk allergy or lactose intolerance - Adults with known B12 deficiency - Adults who consume more than 1 alcoholic drink/day on average (1 drink=12 oz beer, 5 oz wine or 1.5 oz spirits) - Women have been pregnant during the year previous - Women planning a pregnancy in the next year - Women who believe they may become pregnant during the study - Women who have had a known previous neural tube defect affected pregnancy - Adults who are unable to provide informed consent

Additional Information

Official title Bioavailability of Folic Acid and L-5-methyltetrahydrofolic Acid in Fortified Bread: a Randomized Placebo-controlled Trial
Principal investigator Tim Green, PhD
Description See above.
Trial information was received from ClinicalTrials.gov and was last updated in August 2012.
Information provided to ClinicalTrials.gov by University of British Columbia.