Comparison of The Effect of 5-MTHF and Folic Acid Supplementation in Increasing Red Blood Cell Folate in Pregnant Women

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. This study will recruit pregnant women and randomly assign them to receive either 5-MTHF or folic acid supplementation. The primary outcome is the difference in RBC folate levels between the two groups at the end of the study. Secondary outcomes include the proportion of women achieving a target RBC folate level of 906 nM, changes in plasma 5-MTHF, homocysteine, and unmetabolized folic acid (UMFA) levels from baseline to month three (M3). The findings of this study will provide valuable insights into the comparative effectiveness of 5-MTHF and folic acid supplementation in optimizing folate status during pregnancy, potentially informing clinical practice and guidelines. All participants will be provided with detailed information about the study, and their participation will be voluntary. Ethical considerations, including informed consent and data confidentiality, will be strictly adhered to throughout the study.

NCT Number	NCT06935630
Lead Sponsor	Dr. Soetomo General Hospital Collaborators: Simex Pharmaceutical Indonesia
Conditions	Pregnant Women
Enrollment	96 participants
Start Date	2025-01-01
Primary Completion	2026-02-05 (estimated)
Study Completion	2026-02-28 (estimated)
Updated on ClinicalTrials.gov	2026-07-06