Could a simple supplement help manage gestational diabetes?

NCT ID NCT07685015

What the study statuses mean

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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 Results may not be published yet.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

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

Summary

This pilot study investigates whether taking myo-inositol (a vitamin-like substance) along with folic acid can improve blood sugar control and reduce oxidative stress in women diagnosed with gestational diabetes. About 40 pregnant women will be randomly assigned to receive either myo-inositol plus folic acid or folic acid alone until delivery. Researchers will track glucose levels, blood markers, and birth outcomes to see if the supplement offers any benefit.

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 (a vitamin-like substance) plus folic acid
What this could lead to
If effective, myo-inositol could offer a simple dietary supplement to help manage blood sugar in gestational diabetes, potentially reducing the need for insulin.
What could go wrong
This is a small pilot study (40 participants) and is not blinded, so results may be biased or not generalizable. The supplement may not improve outcomes beyond standard folic acid alone.

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 40 people

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

Started

Mar 2026

Expected to finish

Jul 2027

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

18 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: * GDM diagnosis * at least one of the HAPO-Study criteria: 2h-oGTT → \>153 mg/dl, 1h-oGGT → \>180 mg/dl, fasting plasma glucose \> 92 mg/dl * age between 18-45 * single pregnancy Exclusion Criteria: * T2DM * T1DM * Maturity Onset Diabetes of the Young (MODY) * Latent Autoimmune Diabetes in Adults (LADA) * pre pregnancy BMI \>35 * oral antidiabetic drugs * pre-existing renal disease * heart disease and other chronic medical disorders * allergies to any ingredients contained in the dietary supplements

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites. 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.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna

    RECRUITING

    Vienna, State of Vienna, 1090, Austria

  • Medical University of Vienna

    RECRUITING

    Vienna, State of Vienna, 1090, Austria

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