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Could a simple supplement help babies of moms with diabetes?

NCT ID NCT07241221

Disease control Sponsor: National University Hospital, Singapore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether taking myo-inositol (a natural supplement) during pregnancy can improve health outcomes for babies born to mothers with type 2 diabetes. About 182 pregnant women will take either myo-inositol plus folic acid or folic acid alone from early pregnancy until delivery. The goal is to see if the supplement helps babies be born at a healthy weight, at full term, and without needing intensive care.

What this could mean

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

Active substance
myo-inositol and folic acid supplement
What this could lead to
If it works, this could point toward a simple supplement to help babies of mothers with type 2 diabetes be born healthier and at full term.
What could go wrong
This is a small, early feasibility study, not a large definitive trial. The supplement may show no benefit, and results may not apply to all pregnancies.

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

About 182 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

21 to 45 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 aged 21 years to 45 years old at the time of recruitment * Ongoing, viable, singleton intrauterine pregnancy * Between 12+0 days-16+6 days weeks' gestation at recruitment * T2DM diagnosed by a documented 75g Oral Glucose Tolerance Test (OGTT) showing a fasting glucose of \>7 mmol/L or 2h glucose \>11.1 mmol/L, or an HbA1C \>6.5%, either prior to pregnancy or during the first 16 weeks of the index pregnancy * Intend to receive antenatal care and give birth at NUH * Willing to provide written, informed consent * Able to swallow capsules and comply with trial procedures Exclusion Criteria * Known or suspected fetal aneuploidy or genetic/structural anomaly * Severe allergy to food items requiring carriage of an Epipen at all times

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

Birth Weight diabetes mellitus Perinatal Death Premature Birth Stillbirth type 2 diabetes mellitus

As listed by the trial registrant

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

Perinatal and neonatal outcomes in pregnancies with type 2 diabetes mellitus (T2DM)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • National University Hospital

    RECRUITING

    Singapore, Singapore, 119228, Singapore