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Vitamin

High-Dose Folic Acid Supplementation for Metabolic Health During Pregnancy

N/A

Waitlist Available

Led By Yvonne Lamers, PhD

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study Summary

This trial studies how folate (B-vitamin) affects pregnancy outcomes. It will look at two forms of folate to see how they affect metabolism in healthy humans.

Who is the study for?

This trial is for generally healthy individuals with a BMI of 19-24 kg/m2 and normal levels of folate, vitamin B12, and B6. It's not for those who've used certain supplements recently, have chronic diseases like diabetes or asthma, are pregnant or breastfeeding, smoke, use drugs, drink heavily, can't swallow pills or consent in English.Check my eligibility

What is being tested?

The study compares the effects of high-dose folic acid versus a natural form called 5-MTHF on DNA-related cellular mechanisms in humans. Researchers will track how these substances influence metabolic pathways using stable isotope tracer protocols.See study design

What are the potential side effects?

While specific side effects aren't listed for this trial due to the nature of the substances being vitamins at presumably safe doses, potential general side effects could include allergic reactions or gastrointestinal discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Folic acid supplementationExperimental Treatment1 Intervention

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.

Group II: 5-MTHF supplementationExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Folic acid

2008

Completed Phase 4

~8330

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor

1,415 Previous Clinical Trials

2,466,991 Total Patients Enrolled

Yvonne Lamers, PhDPrincipal InvestigatorUniversity of British Columbia

2 Previous Clinical Trials

390 Total Patients Enrolled

Media Library

5-methyltetrahydrofolate, calcium salt (Vitamin) Clinical Trial Eligibility Overview. Trial Name: NCT01687127 — N/A

One-Carbon Metabolism Research Study Groups: Folic acid supplementation, 5-MTHF supplementation

One-Carbon Metabolism Clinical Trial 2023: 5-methyltetrahydrofolate, calcium salt Highlights & Side Effects. Trial Name: NCT01687127 — N/A

5-methyltetrahydrofolate, calcium salt (Vitamin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01687127 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is an eligible participant for this medical experiment?

"Eligibility for this medical experiment is limited to those between the ages of 20 and 35 that possess one-carbon metabolism. Currently, 25 people are being sought after in order to complete the trial."

Answered by AI

Does this study accept participants aged 50 and older?

"The enrollment guidelines for this medical trial require that potential participants are between the age of 20 and 35."

Answered by AI

Can individuals still apply to be a part of this experiment?

"According to clinicaltrials.gov, there are no current recruitment efforts for this medical research study which was initially published on January 1st 2024 and most recently updated August 14th 2023. Nevertheless, one other trial is presently searching for participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Yvonne Lamers 2024. "Impact of High-dose Folic Acid Supplementation on Pathways Linked to DNA Formation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01687127.