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

NCT06935630 | Recruiting DMC

• 1 other identifier: Interventional
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 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

Keywords

Interventional; Folic Acid; Pregnant Women

Outcome Measures

Primary Outcomes (1)

• Change in Red Blood Cell (RBC) Folate Levels

  This measure will assess the difference in RBC folate levels between the 5-MTHF and folic acid supplementation groups. Blood samples will be collected at baseline and at the end of the 3-month intervention period. RBC folate levels will be quantified using a validated laboratory assay to determine the impact of each supplement on folate status. The red blood cell folate (RBC folate) levels in pregnant women who receive 5-MTHF supplementation expected to be higher than those who receive folic acid supplementation.

  Baseline and Month 3 (End of Intervention)

Secondary Outcomes (4)

• Proportion of Participants Achieving Target RBC Folate Level

  Month 3 (End of Intervention)

• Change in Plasma 5-MTHF Levels

  Baseline and Month 3 (End of Intervention)

• Change in Plasma Homocysteine Levels

  Baseline and Month 3 (End of Intervention)

• Change in Plasma UMFA Levels

  Baseline and Month 3 (End of Intervention)

Study Arms (2)

Folic Acid Group

ACTIVE COMPARATOR

This group will receive daily oral supplementation of 600 mcg (1.35 μmol) of folic acid film-coated tablets for a duration of three months. Participants will be instructed to consume the supplement at a consistent time each day. Monitoring for compliance and potential side effects will be conducted throughout the study period

Dietary Supplement: Folic Acid

5-MTHF Group

EXPERIMENTAL

This group will receive daily oral supplementation of 1100 mcg (1.35 μmol) of 5-MTHF glucosamine salt (HY-FOLIC®) film-coated tablets for a duration of three months. Participants will be instructed to consume the supplement at a consistent time each day. Monitoring for compliance and potential side effects will be conducted throughout the study period.

Dietary Supplement: 5-MTHF (5-methyltetrahydrofolate)

Interventions

Folic Acid DIETARY_SUPPLEMENT

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.

Also known as: Folic Acid 600 mcg (1.35 μmol)

Folic Acid Group

5-MTHF (5-methyltetrahydrofolate) DIETARY_SUPPLEMENT

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

Also known as: HY-FOLIC® 1100 mcg

5-MTHF Group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Soetomo General Hospital: lead
• Prodia Diacro Laboratories P.T.: collaborator
• Simex Pharmaceutical Indonesia: collaborator

Study Sites (1)

Mulyorejo Public Health

Surabaya, East Java, 60114, Indonesia

RECRUITING

MeSH Terms

Interventions

Folic Acid; 5-methyltetrahydrofolate

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ernawati Ernawati, Doctor

  Soetomo General Hospital Surabaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ernawati Ernawati, Doctor

CONTACT

+6281232850261; ernawati@fk.unair.ac.id

Qurrata Akyuni, OB/GYN

CONTACT

+628113400305; akyuniqurrata.md@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The folic acid supplementation codes will be blinded (double-blind) until all study phases are completed. This ensures that the participants, investigators, and outcomes assessors are unaware of which intervention each participant is receiving during the study. This helps to minimize potential bias in the evaluation of the treatment outcomes.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 20, 2025
• Study Start: January 1, 2025
• Primary Completion: August 31, 2025
• Study Completion: January 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

ID (1)