Bioavailability of Folic Acid Fortified Bread

University of British Columbia

Status and phase: Completed; Phase 2

Conditions: Red Blood Cell Folate

Treatments: Other: Placebo; Dietary Supplement: L-5-MTHF; Dietary Supplement: Folic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01570088

H12-00339

Details and patient eligibility

About

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.

Full description

See above.

Enrollment: 45 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

45 participants in 3 patient groups, including a placebo group

Folic acid

Active Comparator group

Treatment:

Dietary Supplement: Folic acid

L-5-MTHF

Experimental group

Treatment:

Dietary Supplement: L-5-MTHF

Placebo

Placebo Comparator group

Treatment:

Other: Placebo