High-Dose Folic Acid Supplementation for Metabolic Health During Pregnancy
Trial Summary
Will I have to stop taking my current medications?
Yes, you will need to stop taking long-term prescription medications like hormonal contraceptives, antidepressants, anticonvulsants, anticoagulants, or other chronic medications to participate in this trial.
What data supports the effectiveness of the drug 5-methyltetrahydrofolate, calcium salt, Folic Acid for metabolic health during pregnancy?
Research shows that folic acid supplementation during pregnancy is linked to higher birth weights and lower risks of preeclampsia (a pregnancy complication characterized by high blood pressure) and gestational hypertension (high blood pressure during pregnancy). Additionally, high-dose folic acid supplements have been associated with improved recovery rates in women with gestational diabetes.12345
Is high-dose folic acid supplementation safe during pregnancy?
Research shows that folic acid and its alternative, calcium L-methylfolate, are generally safe for use in humans. Studies found no harmful effects on behavior, body weight, or organ health in animals, and folic acid is widely recommended for pregnant women to support healthy pregnancy outcomes.56789
How does the drug 5-methyltetrahydrofolate, calcium salt, differ from other treatments for metabolic health during pregnancy?
5-methyltetrahydrofolate, calcium salt, is a form of folate that is already in its active form, unlike folic acid which needs to be converted in the body. This may reduce the risk of masking vitamin B12 deficiency symptoms and potentially interacts less with certain medications, making it a unique option for improving folate status during pregnancy.1011121314
What is the purpose of this trial?
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.
Research Team
Yvonne Lamers, PhD
Principal Investigator
University of British Columbia
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either folic acid or 5-MTHF supplementation. Folic acid: 1 mg daily for 12 weeks, then 5 mg daily for 12 weeks. 5-MTHF: 1 mg daily for 12 weeks, then 5 mg daily for 12 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- 5-methyltetrahydrofolate, calcium salt
- Folic Acid
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor