Status:
RECRUITING
Comparison of The Effect of 5-MTHF and Folic Acid Supplementation in Increasing Red Blood Cell Folate in Pregnant Women
Lead Sponsor:
Dr. Soetomo General Hospital
Collaborating Sponsors:
Prodia Diacro Laboratories P.T.
Simex Pharmaceutical Indonesia
Conditions:
Pregnant Women
Eligibility:
FEMALE
25-35 years
Phase:
NA
Brief Summary
This randomized controlled trial aims to compare the efficacy of 5-methyltetrahydrofolate (5-MTHF) and folic acid supplementation in increasing red blood cell (RBC) folate levels in pregnant women. T...
Detailed Description
This prospective, double-blind, randomized controlled trial (RCT) aims to evaluate and compare the efficacy of 5-methyltetrahydrofolate (5-MTHF) and folic acid supplementation in increasing red blood ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06935630
Start Date
January 1 2025
End Date
January 1 2026
Last Update
April 29 2025
Active Locations (1)
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1
Mulyorejo Public Health
Surabaya, East Java, Indonesia, 60114