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Bioavailability of Folic Acid Fortified Bread
This study has been completed.
Sponsor:
University of British Columbia
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01570088
First received: March 16, 2012
Last updated: December 12, 2014
Last verified: December 2014
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Red Blood Cell Folate | Dietary Supplement: Folic acid Dietary Supplement: L-5-MTHF Other: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) |
| Official Title: | Bioavailability of Folic Acid and L-5-methyltetrahydrofolic Acid in Fortified Bread: a Randomized Placebo-controlled Trial |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- red blood cell folate concentration at three time points [ Time Frame: baseline, 8th week, 16th week ]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.
| Enrollment: | 45 |
| Study Start Date: | April 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Folic acid |
Dietary Supplement: Folic acid
One roll/bun per day fortified with 400 µg of folic acid
|
| Experimental: L-5-MTHF |
Dietary Supplement: L-5-MTHF
One roll/bun per day fortified with 452 µg of L-5-MTHF
|
| Placebo Comparator: Placebo |
Other: Placebo
Placebo contains no folic acids
|
Detailed Description:
See above.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01570088
Please refer to this study by its ClinicalTrials.gov identifier: NCT01570088
Locations
| Canada, British Columbia | |
| University of British Columbia | |
| Vancouver, British Columbia, Canada, V6T 1Z4 | |
Sponsors and Collaborators
University of British Columbia
Investigators
| Principal Investigator: | Tim Green, PhD | University of British Columbia |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01570088 History of Changes |
| Other Study ID Numbers: |
H12-00339 |
| Study First Received: | March 16, 2012 |
| Last Updated: | December 12, 2014 |
Additional relevant MeSH terms:
|
Folic Acid Vitamin B Complex Hematinics Vitamins |
Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 23, 2017