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OpenTrials
Completed

NCT Number: NCT01570088

Bioavailability of Folic Acid Fortified Bread

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.

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Key information

Conditions

Red Blood Cell Folate

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

About this study

See above.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Folic Acid

Dietary Supplement

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

L-5-MTHF

Dietary Supplement

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

Placebo

Other

Placebo contains no folic acids

Primary outcomes

  1. red blood cell folate concentration at three time points

    Time frame: baseline, 8th week, 16th week

    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.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Bioavailability of Folic Acid and L-5-methyltetrahydrofolic Acid in Fortified Bread: a Randomized Placebo-controlled Trial

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 4, 2012
Registry last updated
Dec 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.