Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

The goal of this randomized, double-blind, placebo-controlled study included pregnant women at high risk of GDM at 6-15 weeks of gestation is to investigate whether supplementation with vitamin D (1600 IU per day) or prebiotics (inulin, 10 gram per day) during pregnancy has beneficial effects on controlling blood glucose during pregnancy.

About 500 pregnant women aged 18-45 years, at 6-15 weeks of gestation, had resided locally for at least one year, with high risk of GDM will be enrolled in the study. Pregnant women at high risk of GDM are defined as meeting any of the following criteria:

1. Pre-pregnancy body mass index (BMI) ≥24.0 kg/m2;
2. History of GDM or a family history of diabetes;
3. History of delivery of macrosomia (birth weight >4000 g);
4. Glycated hemoglobin (HbA1c) 5.7-6.4% or fasting blood glucose 5.6-7.0 mmol/L; Eligible participants must have singleton pregnancy, no infertility treatment, no history of diabetes or a definite diagnosis of diabetes, or impaired glucose tolerance at recruitment (fasting blood glucose >7.0 mmol/L or HbA1c≥6.5%), no allergic history of chicory root and they will be required to agree to limit the use of vitamin D, prebiotics, probiotics, or synbiotic supplementations and to be convenient access to study centers. Safety exclusions include serious chronic or infectious diseases, serious liver or kidney disease, abnormalities in calcium metabolism, and clinically diagnosed mental disorders, or other conditions that would preclude participation.

Eligible participants will be assigned by chance to one of four groups: (1) daily vitamin D (1600 IU) and prebiotics (10 gram); (2) daily vitamin D (1600 IU) and prebiotics placebo; (3) daily vitamin D placebo and prebiotics (10 gram); or (4) daily vitamin D placebo and prebiotics placebo. Randomization will be conducted.

At enrollment, baseline questionnaires are designed to collect data on sociodemographic factors, pregnancy-related information, lifestyle habits, health status, and medical conditions before and during pregnancy. Participants in all groups will take two capsules that contained either vitamin D or vitamin D placebo and a strip of prebiotics powder (10 g per strip, brew with warm water and take with meals) or prebiotics placebo each day until delivery.