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Which folate supplement works best for Moms-to-Be?

NCT ID NCT06935630

Disease control Sponsor: Dr. Soetomo General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study compares two forms of folate—5-MTHF and folic acid—to see which one better increases red blood cell folate levels in pregnant women. Healthy pregnant women aged 25-35 with a gestational age of 9-14 weeks are randomly assigned to take one of the two supplements daily for three months. The main goal is to measure changes in folate levels and determine if 5-MTHF leads to higher levels than folic acid, which could inform future prenatal care guidelines.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
5-methyltetrahydrofolate (5-MTHF) and folic acid
What this could lead to
If 5-MTHF proves more effective, it could lead to updated prenatal supplement recommendations, potentially improving folate status and reducing neural tube defect risks in pregnancies.
What could go wrong
This is a small, early-phase trial with 96 participants, so results may not apply broadly. The study measures blood folate levels, not actual health outcomes, so real-world benefits remain uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

96 people

The number who actually took part.

Started

Jan 2025

Finished

Feb 2026

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 to 35 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant women with a gestational age of 9-14 weeks * Age: 25 - 35 years old * Have normal BMI (18.5- 30 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pregnant women

Contacts and locations

Locations

  • Mulyorejo Public Health

    Surabaya, East Java, 60114, Indonesia

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