Red Blood Cell Folate Clinical Trial
Official title:
Bioavailability of Folic Acid and L-5-methyltetrahydrofolic Acid in Fortified Bread: a Randomized Placebo-controlled Trial
| Verified date | December 2014 |
| Source | University of British Columbia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Health Canada |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 45 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of British Columbia | Vancouver | British Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| University of British Columbia |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | red blood cell folate concentration at three time points | We will take one blood sample at baseline, 8th and 16th week. For each blood sample, we will measure the red blood cell folate concentration as our primary outcome measure. We will record the changes in the folate concentrations. | baseline, 8th week, 16th week | No |