Comparing 5-MTHF and folic acid for increasing folate in pregnant women
Comparison of The Effect of 5-MTHF and Folic Acid Supplementation in Increasing Red Blood Cell Folate in Pregnant Women : A Randomized Controlled Trial Study
This study is testing whether a new form of folate called 5-MTHF works better than regular folic acid to boost folate levels in pregnant women during their first trimester.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 25 Years to 35 Years |
| Sex | Female |
| Sponsor | Dr. Soetomo General Hospital Government |
| Drugs / interventions | Methotrexate |
| Locations | 1 site (Surabaya, East Java) |
| Trial ID | NCT06935630 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the effectiveness of 5-methyltetrahydrofolate (5-MTHF) versus folic acid supplementation in boosting red blood cell folate levels in pregnant women during their first trimester. A total of 100 participants aged 25-35 years will be recruited and randomly assigned to receive either 5-MTHF or folic acid. The primary outcome is the difference in RBC folate levels between the two groups after three months, while secondary outcomes include various metabolic markers related to folate metabolism. The study aims to provide insights that could optimize folate supplementation strategies and improve maternal and fetal health outcomes.
Who should consider this trial
Good fit: Ideal candidates are healthy pregnant women aged 25-35 years, with a gestational age of 9-14 weeks and a normal BMI.
Not a fit: Patients with gastrointestinal diseases or those on medications that interfere with folate metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved folate supplementation practices during pregnancy, enhancing maternal and fetal health.
How similar studies have performed: Previous studies have indicated the importance of folate in pregnancy, but this specific comparison of 5-MTHF and folic acid is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women with a gestational age of 9-14 weeks * Age: 25 - 35 years old * Have normal BMI (18.5-24.9 kg/m2) * Declared healthy based on previous health examinations * Hb \> 11 g/dl Exclusion Criteria: * Pregnant women with upper gastrointestinal disease * History or current use of drugs interacting with folate metabolism (e.g., Methotrexate) * History or current use of antiepileptic therapy * Concomitant use of Proton Pump Inhibitors (PPI), antacid, and AH2 receptor blocker
Where this trial is running
Surabaya, East Java
- Mulyorejo Public Health — Surabaya, East Java, Indonesia (Recruiting)
Study contacts
- Principal investigator: Ernawati Ernawati, Doctor — Soetomo General Hospital Surabaya
- Study coordinator: Ernawati Ernawati, Doctor
- Email: ernawati@fk.unair.ac.id
- Phone: +6281232850261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.