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

NCT06935630 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-04-29

No results posted yet for this study

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.

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.

Conditions

  • Pregnant Women

Interventions

DIETARY_SUPPLEMENT

Folic Acid

Participants in this group will receive a daily oral dose of 600 mcg (1.35 μmol) of folic acid in film-coated tablet form for a duration of three months. This synthetic form of folate will be administered to assess its impact on red blood cell folate levels compared to 5-MTHF.

DIETARY_SUPPLEMENT

5-MTHF (5-methyltetrahydrofolate)

Participants in this group will receive a daily oral dose of 1100 mcg (1.35 μmol) of 5-methyltetrahydrofolate (5-MTHF) glucosamine salt, specifically HY-FOLIC®, in film-coated tablet form for a duration of three months. This active form of folate will be administered to assess its impact on red blood cell folate levels compared to folic acid

Sponsors & Collaborators

  • Prodia Diacro Laboratories P.T.

    collaborator INDUSTRY

  • Simex Pharmaceutical Indonesia

    collaborator UNKNOWN

  • Dr. Soetomo General Hospital

    lead OTHER_GOV

Principal Investigators

  • Ernawati Ernawati, Doctor · Soetomo General Hospital Surabaya

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-08-31
Completion
2026-01-01

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06935630 on ClinicalTrials.gov