Comparison of The Effect of 5-MTHF and Folic Acid Supplementation in Increasing Red Blood Cell Folate in Pregnant Women
Launched by DR. SOETOMO GENERAL HOSPITAL · Apr 11, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how well two different types of folate supplements—5-methyltetrahydrofolate (5-MTHF) and folic acid—help increase folate levels in red blood cells of pregnant women. Folate is important for both the mother and the developing baby, and this study aims to find out which supplement is more effective. Pregnant women aged 25 to 35, who are between 9 to 14 weeks along in their pregnancy and have a healthy body weight, may be eligible to participate.
If you join the study, you will be randomly assigned to receive either 5-MTHF or folic acid for three months. Researchers will measure your red blood cell folate levels at the end of the study to see how well each supplement worked. Participation is voluntary, and you will receive detailed information about the study before you decide. The study will also prioritize your privacy and ensure ethical standards are followed throughout the process.
Gender
FEMALE
Eligibility 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
About Dr. Soetomo General Hospital
Dr. Soetomo General Hospital is a leading healthcare institution dedicated to advancing medical research and improving patient care through innovative clinical trials. Committed to excellence, the hospital operates with a multidisciplinary approach, harnessing the expertise of its diverse team of healthcare professionals to conduct rigorous and ethically sound studies. By prioritizing patient safety and scientific integrity, Dr. Soetomo General Hospital aims to contribute valuable insights to the medical community and enhance treatment options for patients across various conditions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Surabaya, East Java, Indonesia
Patients applied
Trial Officials
Ernawati Ernawati, Doctor
Principal Investigator
Soetomo General Hospital Surabaya
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported