Impact of High-dose Folic Acid Supplementation on Pathways Linked to DNA Formation
|ClinicalTrials.gov Identifier: NCT01687127|
Recruitment Status : Unknown
Verified May 2017 by Yvonne Lamers, University of British Columbia.
Recruitment status was: Not yet recruiting
First Posted : September 18, 2012
Last Update Posted : May 3, 2017
Periconceptional supplementation with folic acid - the synthetic form of the B-vitamin folate - reduces the occurrence of adverse pregnancy outcomes such as spina bifida. The underlying biochemical mechanisms for how folic acid affects health outcomes however are unknown. The naturally occurring form 5-methyltetrahydrofolate (5-MTHF) is now available and discussed as an adequate substitute to folic acid. This study aims to determine the effect of folic acid compared to 5-MTHF on cellular mechanisms. Stable isotope tracer protocols will be used that allow determining the effect of folic acid on the dynamics of metabolic pathways in the human body.
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.
|Condition or disease||Intervention/treatment||Phase|
|One-carbon Metabolism in Healthy Individuals||Dietary Supplement: Folic acid Dietary Supplement: 5-methyltetrahydrofolate, calcium salt||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Metabolic Consequences of High-Dose Folic Acid Supplementation on Kinetics of 1-Carbon Metabolism|
|Estimated Study Start Date :||July 1, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Experimental: 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.
Dietary Supplement: Folic acid
Other Name: Pteroylmonoglutamic acid
Experimental: 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.
Dietary Supplement: 5-methyltetrahydrofolate, calcium salt
- Plateau enrichment of infused amino acid tracers and related metabolites to quantify turnover rates of folate dependent pathways [ Time Frame: 24 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687127
|Contact: Yvonne Lamers, PhDemail@example.com|
|Contact: Amy McMahon, PhDfirstname.lastname@example.org|
|Canada, British Columbia|
|Children's and Women's Health Centre of BC (incl. Sunny Hill), Child and Family Research Institute|
|Vancouver, British Columbia, Canada, V5Z 4H4|
|Contact: Yvonne Lamers, PhD 604-827-1776 email@example.com|
|Contact: Amy McMahon, PhD 604-822-1250 firstname.lastname@example.org|
|Sub-Investigator: Jehannine C Austin, PhD|
|Sub-Investigator: Amanda Skoll, MD, FRCSC|
|Principal Investigator:||Yvonne Lamers, PhD||University of British Columbia|