Effects of Vitamin D and Prebiotic Supplementation on Glucose Control During Pregnancy
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 6-15 weeks of gestation. 2. Age 18-45 years old. 3. Permanent resident or resident locally at least one year. 4. GDM high-risk pregnant women (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. HbA1c 5.7-6.4% or fasting blood glucose 5.6-7.0 mmol/L. Exclusion Criteria: 1. Multiple pregnancy. 2. Have received infertility treatment such as in vitro fertilization or intrauterine insemination. 3. History of diabetes or current diagnosis of diabetes (including type 1 and type 2 diabetes) or abnormal glucose tolerance at recruitment (fasting blood glucose \>7.0 mmol/L or HbA1c≥6.5%). 4. Serious chronic diseases (including cardiovascular and cerebrovascular diseases, cancer, and thyroid dysfunction) or infectious diseases (including hepatitis B, active tuberculosis, acquired immunodeficiency syndrome, and syphilis).