Impact of High-dose Folic Acid Supplementation on Pathways Linked to DNA Formation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01687127|
Recruitment Status : 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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||Not yet recruiting|
|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|