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Search / Trial NCT06935630

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

Interventional Folic Acid Pregnant Women

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.

Locations

Surabaya, East Java, Indonesia

Patients applied

0 patients applied

Trial Officials

Ernawati Ernawati, Doctor

Principal Investigator

Soetomo General Hospital Surabaya

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported