Bioavailability of Folic Acid Fortified Bread
This trial is active, not recruiting.
|Condition||red blood cell folate|
|Treatments||folic acid, l-5-mthf, placebo|
|Sponsor||University of British Columbia|
|Start date||April 2012|
|End date||December 2012|
|Trial size||90 participants|
|Trial identifier||NCT01570088, H12-00339|
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.
|Endpoint classification||bio-availability study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
red blood cell folate concentration at three time points
time frame: baseline, 8th week, 16th week
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
|Official title||Bioavailability of Folic Acid and L-5-methyltetrahydrofolic Acid in Fortified Bread: a Randomized Placebo-controlled Trial|
|Principal investigator||Tim Green, PhD|
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