NCT01584050

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2012

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

August 10, 2012

Status Verified

August 1, 2012

Enrollment Period

2 months

First QC Date

April 20, 2012

Last Update Submit

August 9, 2012

Conditions

Vitamin B12 Deficiency

Outcome Measures

Primary Outcomes (1)

  • Red cell folate (nmol/L)

    Measured at baseline, 6 weeks, 12 weeks

    12 weeks

Study Arms (3)

L-MTHF

ACTIVE COMPARATOR
Dietary Supplement: L-5-methyltetrahydrofolate (Metafolin ®)

folic acid

ACTIVE COMPARATOR
Dietary Supplement: folic acid

placebo (methyl cellulose)

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

L-5-methyltetrahydrofolate (Metafolin ®)DIETARY_SUPPLEMENT

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

L-MTHF
folic acidDIETARY_SUPPLEMENT

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

folic acid
PlaceboDIETARY_SUPPLEMENT

frequency: once daily, duration: 12 weeks

placebo (methyl cellulose)

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Malaysian nationality

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of British Columbia

Vancouver, British Columbia, Canada

Location

Universiti Putra Malaysia

Serdang, Selangor, Malaysia

Location

Related Publications (1)

  • Henderson AM, Aleliunas RE, Loh SP, Khor GL, Harvey-Leeson S, Glier MB, Kitts DD, Green TJ, Devlin AM. l-5-Methyltetrahydrofolate Supplementation Increases Blood Folate Concentrations to a Greater Extent than Folic Acid Supplementation in Malaysian Women. J Nutr. 2018 Jun 1;148(6):885-890. doi: 10.1093/jn/nxy057.

    PMID: 29878267DERIVED

MeSH Terms

Conditions

Vitamin B 12 Deficiency

Interventions

5-methyltetrahydrofolatelevomefolate calciumFolic Acid

Condition Hierarchy (Ancestors)

Vitamin B DeficiencyAvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Tim Green, PhD

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 24, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 10, 2012

Record last verified: 2012-08

Locations

MY(1)CA(1)