A clinical trial to investigate the effect of vitamin D supplementation on glucose status in mothers with gestational diabetes

The main objective of this study is determining the effect of vitamin D supplementation on glucose status in mothers with gestational diabetes. This investigation is a randomized controlled clinical trial on 40 pregnant women with gestational diabetes in first trimester who are admitted in gynecology clinic in Kerman. Inclusion criteria: women over 18 year-old and gestational age of 18 to 13 week. Exclusion criteria: kidney or hepatic failure; alcoholism; malabsorption; hypo or hyperparathyroidism; malignancies; consumption of drugs affecting vitamin D metabolism; using vitamin D supplements; history of diabetes. Glucose Tolerance Test (GTT) is done by injecting 75 gr Glucose and patients with abnormal results are divided into two groups using simple randomization. Both groups will have nutritional regimen. Beside this regimen, in intervention group oral vitamin D (50000 IU) is given every two weeks for three doses and control group does not receive any supplemental vitamin D. During this period, patients who need insulin will be excluded. Two weeks following the last dose of vitamin D, FBS, fasting insulin and HbA1c level will be measured and HOMA-IR is calculated. Also the patients will be observed for gestational problems including intrauterine fetal death (IUFD), Intrauterine growth restriction (IUGR), Large for gestational age (LGA), preeclampsia, premature birth, abortion and requirement for insulin regimen until the end of pregnancy. After labour, a sample of umbilical cord is taken for measuring vitamin D level and the association of it with gestational problems will be determined.

Kerman University of Medical Sciences