NCT01687127

Impact of High-dose Folic Acid Supplementation on Pathways Linked to DNA Formation

Metabolic Consequences of High-Dose Folic Acid Supplementation on Kinetics of 1-Carbon Metabolism

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• One-carbon Metabolism in Healthy Individuals

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Folic acid	Supplement
DIETARY_SUPPLEMENT	5-methyltetrahydrofolate, calcium salt	Supplement

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2012-09-18
• Last updated: 2023-08-15

Locations

1 site across 1 country: Canada