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Bioavailability of Folic Acid Fortified Bread

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01570088
First received: March 16, 2012
Last updated: August 9, 2012
Last verified: August 2012
History of Changes

March 16, 2012
August 9, 2012
April 2012
December 2012   (final data collection date for primary outcome measure)
red blood cell folate concentration at three time points [ Time Frame: baseline, 8th week, 16th week ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01570088 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Bioavailability of Folic Acid Fortified Bread
Bioavailability of Folic Acid and L-5-methyltetrahydrofolic Acid in Fortified Bread: a Randomized Placebo-controlled Trial

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.

See above.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Red Blood Cell Folate
  • Dietary Supplement: Folic acid
    One roll/bun per day fortified with 400 µg of folic acid
  • Dietary Supplement: L-5-MTHF
    One roll/bun per day fortified with 452 µg of L-5-MTHF
  • Other: Placebo
    Placebo contains no folic acids
  • Active Comparator: Folic acid
    Intervention: Dietary Supplement: Folic acid
  • Experimental: L-5-MTHF
    Intervention: Dietary Supplement: L-5-MTHF
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01570088
H12-00339
No
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Tim Green, PhD University of British Columbia
University of British Columbia
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP