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NCT Number: NCT01687127

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

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.

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's and Women's Health Centre of BC (incl. Sunny Hill), Child and Family Research Institute

Vancouver, British Columbia, V5Z 4H4, Canada

Location contact

Amanda Skoll, MD, FRCSC

SUB_INVESTIGATOR

Amy McMahon, PhD

CONTACT

[email protected]

604-822-1250

Jehannine C Austin, PhD

SUB_INVESTIGATOR

Yvonne Lamers, PhD

CONTACT

[email protected]

604-827-1776

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Generally healthy
  • Body mass index of between 19-24 kg/m2
  • Normal folate, vitamin B12, and B6 status

Exclusion criteria

  • Unable to swallow tablets
  • 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

Treatment and study plan

Folic Acid

Dietary Supplement

Supplement

Other names: Pteroylmonoglutamic acid

5-methyltetrahydrofolate, calcium salt

Dietary Supplement

Supplement

Other names: 5-MTHF, Metafolin (brand name), Levomefolic acid

Primary outcomes

  1. Plateau enrichment of infused amino acid tracers and related metabolites to quantify turnover rates of folate dependent pathways

    Time frame: 24 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Amy McMahon, PhD

CONTACT

[email protected]

604-822-1250

Yvonne Lamers, PhD

CONTACT

[email protected]

604-827-1776

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2012
Registry last updated
Aug 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.