What side effects are associated with this type of intervention?

Common side effects of folic acid supplementation include gastrointestinal issues such as nausea, bloating, and loss of appetite. High doses of folic acid may also mask vitamin B12 deficiency, potentially leading to neurological damage if left untreated. Additionally, there is some evidence suggesting that high serum levels of folic acid may be associated with an increased risk of certain cancers, such as prostate cancer. It is important to monitor and manage these side effects under medical supervision.

What prior FDA approvals exist?

The FDA has approved several treatments related to one-carbon metabolism, particularly those involving folic acid and its derivatives. Folic acid is a synthetic form of the B-vitamin folate, essential for DNA synthesis and repair. Another compound, 5-methyltetrahydrofolate (5-MTHF), is a naturally occurring form of folate that is also discussed as an adequate substitute for folic acid. These agents are crucial in managing conditions that require modulation of folate-dependent pathways, such as certain types of anemia and during periconceptional periods to prevent neural tube defects.

What other types of research exist?

5-methyltetrahydrofolate (5-MTHF) is a promising, novel alternative to folic acid for patients concerned about the turnover rate of folate-dependent pathways in one-carbon metabolism.

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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

Must not have

Unable to swallow tablets

Unable to receive intravenous catheters

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares synthetic folic acid and natural 5-MTHF to see how they affect nutrient processing in healthy people. It uses special tracking methods to observe these changes and considers genetic differences in a key enzyme. 5-MTHF is a natural form of folate that is well absorbed and more bioavailable than synthetic folic acid, even in individuals with metabolic defects.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I cannot swallow pills.

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I cannot have IV lines inserted.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Folic acid, a synthetic form of folate, plays a critical role in One-Carbon Metabolism by aiding in the synthesis of nucleotides and the remethylation of homocysteine to methionine, which are essential for DNA synthesis and repair. High-dose folic acid supplementation can alter the turnover rate of folate-dependent pathways, impacting cellular functions and overall metabolic health. This is particularly important for patients with One-Carbon Metabolism disorders, as it helps manage conditions like hyperhomocysteinemia and supports overall cellular health.