Actively Recruiting
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
Led by Dr. Soetomo General Hospital · Updated on 2025-04-29
100
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
D
Dr. Soetomo General Hospital
Lead Sponsor
P
Prodia Diacro Laboratories P.T.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of 5-methyltetrahydrofolate (5-MTHF) compared to folic acid supplements in pregnant women during their first trimester. This study aims to determine which supplement more effectively increases red blood cell (RBC) folate levels, which are important for DNA synthesis and reducing risks of pregnancy complications such as neural tube defects and pre-eclampsia. The trial involves healthy pregnant women aged 25 to 35 years with normal body mass index (BMI) and hemoglobin levels, ensuring a focused and valid comparison. Participants will be randomly assigned to one of two groups: one group will take a daily oral dose of 600 mcg of folic acid tablets, while the other group will take 1100 mcg of 5-MTHF glucosamine salt tablets, both for three months. The dosages are equimolar to compare the active forms of folate. All participants will take their assigned supplement at the same time each day, with compliance and any side effects monitored throughout the study. During the study, blood samples will be collected at the start and end of the three-month period to measure changes in RBC folate, plasma 5-MTHF, homocysteine, and unmetabolized folic acid levels. The main outcome measured is the difference in RBC folate levels between the two groups after supplementation. Participants will also be closely monitored for safety, have the option to withdraw at any time, and their privacy and informed consent will be strictly maintained.
CONDITIONS
Brief Title
Comparison of The Effect of 5-MTHF and Folic Acid Supplementation in Increasing Red Blood Cell Folate in Pregnant Women
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women with a gestational age of 9-14 weeks
- Age between 25 and 35 years old
- Normal body mass index (BMI) between 18.5 and 24.9 kg/m2
- Declared healthy based on previous health examinations
- Hemoglobin level above 11 g/dL
You will not qualify if you...
- Pregnant women with upper gastrointestinal disease
- History or current use of drugs that interact with folate metabolism such as methotrexate
- History or current use of antiepileptic therapy
- Use of proton pump inhibitors (PPIs), antacids, or H2 receptor blockers in the past three months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive daily oral supplementation with either 600 mcg folic acid or 1100 mcg 5-MTHF glucosamine salt for three months to assess effects on red blood cell folate levels.
2 visits (baseline and end of month 3) to collect blood samples and monitor compliance
Trial Site Locations
Total: 1 location
1
Mulyorejo Public Health
Surabaya, East Java, Indonesia, 60114
Actively Recruiting
Research Team
E
Ernawati Ernawati, Doctor
Q
Qurrata Akyuni, OB/GYN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here