Bioavailability of Folic Acid Fortified Bread

NCT01570088 | Completed Phase 2

• 1 other identifier: H12-00339
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Red Blood Cell Folate

Outcome Measures

Primary Outcomes (1)

• red blood cell folate concentration at three time points

  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.

  baseline, 8th week, 16th week

Study Arms (3)

Folic acid

ACTIVE COMPARATOR

Dietary Supplement: Folic acid

L-5-MTHF

EXPERIMENTAL

Dietary Supplement: L-5-MTHF

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Folic acid DIETARY_SUPPLEMENT

One roll/bun per day fortified with 400 µg of folic acid

Folic acid

L-5-MTHF DIETARY_SUPPLEMENT

One roll/bun per day fortified with 452 µg of L-5-MTHF

L-5-MTHF

Placebo OTHER

Placebo contains no folic acids

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years
• Not taking a folic acid containing supplement

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

Related Publications (1)

• Green TJ, Liu Y, Dadgar S, Li W, Bohni 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.

  PMID: 23616513 DERIVED

MeSH Terms

Interventions

Folic Acid; 5-methyltetrahydrofolate

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tim Green, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: April 4, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 16, 2014

Record last verified: 2014-12

Locations

CA (1)