Relative Bioavailability of Folic Acid and L-5-Methlytetrahydrofolate

Folic acid, a form of the vitamin folate, is added to grain products in Canada to help reduce birth defects. Folic acid is the synthetic form of folate and is very stable (doesn't break down) when added to foods. There are emerging health concerns about chronic folic acid consumption. Recently another more natural form of folate, L-5-methyltetrahydrofolate (L-MTHF) has become available. The investigators plan to conduct a randomized trial in women to determine if supplements containing L-MTHF consumed over three months raises blood folate levels as much as supplements containing folic acid. The investigators hypothesize that L-MTHF will increase red cell folate over 12 weeks to same extent as equimolar folic acid.

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Key information

Conditions

Vitamin B12 Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin B 12 Deficiency Vitamin B Deficiency

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of British Columbia, Vancouver, British Columbia, Canada

About this study

The proposed study is a twelve week, cross-sectional, double blind, randomized controlled trial. The sample population will consist of one-hundred fifty healthy adult volunteers. All participants will be Malaysian women between eighteen and forty-two years of age. Study participants will be recruited by word of mouth and through advertisements placed in hospitals and universities starting in January 2011. Study participants will be randomly assigned to 1 of 3 treatment groups: 1) 1000ug L-MTHF 2) 1000ug folic acid 3) placebo (methyl cellulose). All treatments will be given in capsule form. Blood samples will be collected at baseline, 6 and 12 weeks.

The primary outcome measure is red cell folate. A sample size of 45 subjects per group will allow us to detect a minimum difference of 100 nmol/L red cell folate assuming an alpha 0.05, a beta of 0.8 a SD of 183 nmol/L. Accounting for a 10% attrition rate we will enroll 50 women per group. The study will be analyzed as intent to treat. Baseline characteristics and compliance between treatment groups will be compared using a one-way ANOVA for continuous variables and chi-square analyses for categorical variables. The difference in measurements between the treatment groups at week 12 will be determined by regression analysis, controlling for baseline values.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Malaysian nationality

Exclusion criteria

Pregnancy
Vitamin supplement users
Chronic disease
prior neural tube defect affected pregnancy

Treatment and study plan

L-5-methyltetrahydrofolate (Metafolin ®)

Dietary Supplement

dosage: 1000 μg, frequency: once daily, duration: 12 weeks

Folic Acid

Dietary Supplement

dosage: 1000 μg, frequency: once daily, duration: 12 weeks

Placebo

Dietary Supplement

frequency: once daily, duration: 12 weeks

Primary outcomes

Red cell folate (nmol/L)

Time frame: 12 weeks

Measured at baseline, 6 weeks, 12 weeks

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Apr 24, 2012
Registry last updated: Aug 10, 2012

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.

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Completed