RecruitingNot ApplicableNCT07241221

Antenatal Myo-inositol Supplementation in Pre-existing Diabetes

Antenatal Myo-inositol Supplementation in Pre-existing Diabetes to Promote Normal Neonatal Outcomes


Sponsor

National University Hospital, Singapore

Enrollment

182 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This feasibility pilot study aims to gather data that can guide the design of a larger, more comprehensive trial to establish the effects of myo-inositol supplementation on supporting healthy outcomes in pregnancies complicated by Type 2 Diabetes Mellitus (T2DM). It seeks to assess myo-inositol's potential to support fetal and neonatal health, and optimise maternity outcomes as a complementary approach and adjuvant to existing diabetes mellitus therapies, as well as investigate the underlying biological mechanisms.


Eligibility

Sex: FEMALEMin Age: 21 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a supplement called myo-inositol — a naturally occurring sugar-like compound — can help improve blood sugar control and pregnancy outcomes in women who had diabetes (Type 2 or gestational) before or early in pregnancy. **You may be eligible if...** - You are a pregnant woman aged 21–45 years - You are carrying a single baby and your pregnancy is viable - You are 12 to nearly 17 weeks pregnant at the time of enrollment - You have Type 2 diabetes (diagnosed before pregnancy or very early in pregnancy, confirmed by specific test results) - You plan to receive prenatal care and deliver at National University Hospital (NUH) - You can swallow capsules and follow study procedures **You may NOT be eligible if...** - Your baby has a known or suspected chromosomal or structural abnormality - You have a severe food allergy requiring you to carry an EpiPen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTMyo-inositol and folic acid supplement

Participants will take 4 capsules in the morning and 4 capsules in the evening, each capsule containing 500 mg of myo-inositol and 37.5 mcg of folic acid. Capsules are to be swallowed whole with a drink, starting from 12-16 weeks' gestation and continued until delivery.

DIETARY_SUPPLEMENTFolic acid supplement

Participants will take 4 capsules in the morning and 4 capsules in the evening, each capsule containing 37.5 mcg of folic acid. Capsules are to be swallowed whole with a drink, starting from 12-16 weeks' gestation and continued until delivery.


Locations(1)

National University Hospital

Singapore, Singapore, Singapore

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NCT07241221