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
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ 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.


Estimated Enrollment: 90
Study Start Date: April 2012
Estimated Study Completion Date: December 2012
Estimated 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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by University of British Columbia

Additional 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: August 9, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Folic Acid
Vitamin B Complex
Hematinics
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014