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Relative Bioavailability of Folic Acid and L-5-Methlytetrahydrofolate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01584050
First received: April 20, 2012
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention
Vitamin B12 Deficiency
 Dietary Supplement: L-5-methyltetrahydrofolate (Metafolin ®)
Dietary Supplement: folic acid
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Relative Bioavailability of Folic Acid and L-5-Methlytetrahydrofolate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Red cell folate (nmol/L) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Measured at baseline, 6 weeks, 12 weeks


Enrollment: 150
Study Start Date: May 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: L-MTHF Dietary Supplement: L-5-methyltetrahydrofolate (Metafolin ®)
dosage: 1000 μg, frequency: once daily, duration: 12 weeks
Active Comparator: folic acid Dietary Supplement: folic acid
dosage: 1000 μg, frequency: once daily, duration: 12 weeks
Placebo Comparator: placebo (methyl cellulose) Dietary Supplement: Placebo
frequency: once daily, duration: 12 weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Malaysian nationality

Exclusion Criteria:

  • Pregnancy
  • Vitamin supplement users
  • Chronic disease
  • prior neural tube defect affected pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01584050

Locations
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Malaysia
Universiti Putra Malaysia
Serdang, Selangor, Malaysia
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Tim Green, PhD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01584050     History of Changes
Other Study ID Numbers: H10-03426
Study First Received: April 20, 2012
Last Updated: August 9, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Vitamin B 12 Deficiency
Vitamin B Deficiency
Deficiency Diseases
Vitamin B Complex
Vitamins
Avitaminosis
Malnutrition
Nutrition Disorders
 Folic Acid
Hematinics
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013