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Bioavailability of Folic Acid Fortified Bread

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ClinicalTrials.gov Identifier: NCT01570088
Recruitment Status : Completed
First Posted : April 4, 2012
Last Update Posted : December 16, 2014
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Red Blood Cell Folate Dietary Supplement: Folic acid Dietary Supplement: L-5-MTHF Other: Placebo Phase 2

Detailed Description:
See above.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: Bioavailability of Folic Acid and L-5-methyltetrahydrofolic Acid in Fortified Bread: a Randomized Placebo-controlled Trial
Study Start Date : April 2012
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: April 4, 2012    Key Record Dates
Last Update Posted: December 16, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
 Micronutrients
Growth Substances
Physiological Effects of Drugs