The Impact of Vitamin D Supplementation on Pregnant Women With the Risk of GDM

Overview

A clinical trial will be conducted in Chemical pathology department in collaboration with Gyne \&Obs department of PRH, IIMC over a period of 02 years w.e.f. December 15, 2023. 350 pregnant women with 07-11 weeks of gestation and having a high risk for GDM with low Vitamin D3 levels and normal response to 75g OGTT will be randomly assigned to receive either vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks or Placebo. These women will be checked for the diagnosis of GDM with 75 g OGTT at 24- 28 weeks of gestation. The outcome of the study will be the incidence of GDM based on the International Association of Diabetes and Pregnancy Study Groups Criteria.

Gestational diabetes mellitus is a common condition among pregnant women with metabolic implications for both the mother and offspring. Studies have suggested a potential role of vitamin D status in GDM risk, but evidence from randomized controlled trials is inadequate and inconclusive. A research has been planned to investigate the effect of vitamin D supplementation on GDM development among high risk pregnant women through a well-designed RCT Pregnant women at a risk to develop GDM with low vitamin D levels (\<30 ng/mL) at 07-11 weeks of gestation will be recruited and randomly assigned to receive either vitamin D3 supplementation (2 00,000 IU/Week) for 04 -06 weeks or placebo. Randomization will be achieved using a computer-generated random sequence or a randomization table. The allocation will be done in a 1:1 ratio, with equal numbers of participants assigned to the vitamin D and placebo groups. The primary outcome will be the incidence of GDM based on the International Association of Diabetes and Pregnancy Study Groups Criteria after 75 g OGTT. This study will contribute to the understanding of the relationship between vitamin D and GDM risk through a well-designed RCT with integrated approaches. The findings may inform clinical practice and public health recommendations for vitamin D supplementation during pregnancy.