Randomized Study of Vitamin D and Prebiotic Supplements to Improve Blood Sugar Control in Pregnant Women at High Risk of Gestational Diabetes

What this Trial Is About

This research aims to evaluate whether taking vitamin D or prebiotics during pregnancy can help control blood sugar levels in women at high risk for gestational diabetes mellitus GDM. It is a randomized, double-blind, placebo-controlled trial including about 500 pregnant women aged 18 to 45 years who are between 6 and 15 weeks of pregnancy and meet specific risk criteria for GDM, such as high body mass index, family history of diabetes, or previous pregnancy complications. Participants will be randomly assigned to one of four groups vitamin D plus prebiotics, vitamin D plus prebiotics placebo, prebiotics plus vitamin D placebo, or double placebo. They will take daily capsules and powders containing either the active supplements or placebos until delivery. The study includes three follow-up visits during pregnancy at 24-28 weeks, 32-36 weeks, and at delivery to monitor progress and collect samples. During these visits, researchers will measure height, weight, blood pressure, blood sugar, vitamin D levels, inflammatory markers, and gut bacteria. Blood, urine, and stool samples will be collected for analysis. The main outcomes are fasting blood glucose and glycated hemoglobin HbA1c levels. Secondary outcomes include GDM incidence, blood lipids, delivery details, and pregnancy complications. This monitoring will continue through delivery to assess the impact of the supplements on glucose control and pregnancy outcomes.

Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy