Bioavailability of Folic Acid Fortified Bread - Full Text View

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:

MedlinePlus related topics: B Vitamins

Drug Information available for: Folic acid Vitamin B Complex

U.S. FDA Resources

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.


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
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):

Green TJ, Liu Y, Dadgar S, Li W, Böhni 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.


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
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on March 03, 2015