Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-25 @ 2:43 AM
NCT ID:
NCT06139133
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT06139133
Study Brief:
Protocol Section:
NCT06139133