Bioavailability of Folic Acid Fortified Bread

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01570088

Enrollment

Registered

2012-04-04

Start date

2012-04-30

Completion date

2012-12-31

Last updated

2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Red Blood Cell Folate

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.

Detailed description

See above.

Interventions

DIETARY_SUPPLEMENTFolic acid

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

DIETARY_SUPPLEMENTL-5-MTHF

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

OTHERPlacebo

Placebo contains no folic acids

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
red blood cell folate concentration at three time points	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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026