Impact of High-dose Folic Acid Supplementation on Pathways Linked to DNA Formation
NCT ID: NCT01687127
Last Updated: 2023-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
25 participants
INTERVENTIONAL
2024-01-01
2026-12-31
Brief Summary
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Hypothesis: Supplementation with high-dose folic acid alters the turnover rate of folate dependent pathways in healthy humans; but 5-MTHF does not. Genetic variations in a key enzyme of the folate metabolism will aggravate the effect of folic acid on the metabolic pathways.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Folic acid supplementation
Folic acid will be given orally in form of tablets. A supplement of 1 mg will be taken daily for 12 weeks. Thereafter, a supplement of 5 mg will be taken daily for 12 weeks (i.e., until Week 24). At baseline, Week 12, and Week 24, subjects will receive a 9-hour primed constant infusion of amino acids in saline solution for quantification of kinetics of one-carbon metabolism.
Folic acid
Supplement
5-MTHF supplementation
The calcium salt of 5-methyltetrahydrofolate (5-MTHF; Brand name "Metafolin") will be given orally in form of tablets. A supplement of 1 mg will be taken daily for 12 weeks. Thereafter, a supplement of 5 mg will be taken daily for 12 weeks (i.e., until Week 24). At baseline, Week 12, and Week 24, subjects will receive a 9-hour primed constant infusion of amino acids in saline solution for quantification of kinetics of one-carbon metabolism.
5-methyltetrahydrofolate, calcium salt
Supplement
Interventions
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Folic acid
Supplement
5-methyltetrahydrofolate, calcium salt
Supplement
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Body mass index of between 19-24 kg/m2
* Normal folate, vitamin B12, and B6 status
Exclusion Criteria
* Unable to receive intravenous catheters
* Use of vitamin supplements, amino acid or protein supplements for more than six months before study participation
* Chronic consumption of a high-protein diet (e.g. Atkins Diet)
* Medical conditions such as diabetes, asthma, cancer, cardiovascular disease, a history of neural tube defect (such as spina bifida) affected pregnancy, have had gastrointestinal surgery, abnormal kidney, thyroid function, or psychiatric illness, or any other chronic disease
* Pregnancy or lactation
* Smoking, use of recreational drugs, and/or consumption of more than one alcohol drink per day or more than seven per week.
* Use of long-term prescription medication such as hormonal contraceptives, antidepressants, anticonvulsants, anticoagulants, or other chronic medication
* Blood donation in the last three months prior to study start
* Unable to provide informed consent, or unable to read and write English
* Low compliance to intervention as determined by early steady-state or reduction in blood folate concentrations
20 Years
35 Years
FEMALE
Yes
Sponsors
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University of British Columbia
OTHER
Responsible Party
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Yvonne Lamers
Principal Investigator
Principal Investigators
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Yvonne Lamers, PhD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Children's and Women's Health Centre of BC (incl. Sunny Hill), Child and Family Research Institute
Vancouver, British Columbia, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CIHR Application Nr. 247226
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H11-03009
Identifier Type: -
Identifier Source: org_study_id
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