Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2012-04-30
2012-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Folic acid
Folic acid
One roll/bun per day fortified with 400 µg of folic acid
L-5-MTHF
L-5-MTHF
One roll/bun per day fortified with 452 µg of L-5-MTHF
Placebo
Placebo
Placebo contains no folic acids
Interventions
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Folic acid
One roll/bun per day fortified with 400 µg of folic acid
L-5-MTHF
One roll/bun per day fortified with 452 µg of L-5-MTHF
Placebo
Placebo contains no folic acids
Eligibility Criteria
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Inclusion Criteria
* Not taking a folic acid containing supplement
Exclusion Criteria
* 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
18 Years
45 Years
ALL
Yes
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Principal Investigators
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Tim Green, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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University of British Columbia
Vancouver, British Columbia, Canada
Countries
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References
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Green TJ, Liu Y, Dadgar S, Li W, Bohni R, Kitts DD. Wheat rolls fortified with microencapsulated L-5-methyltetrahydrofolic acid or equimolar folic acid increase blood folate concentrations to a similar extent in healthy men and women. J Nutr. 2013 Jun;143(6):867-71. doi: 10.3945/jn.113.174268. Epub 2013 Apr 24.
Other Identifiers
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H12-00339
Identifier Type: -
Identifier Source: org_study_id