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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IIMC, Riphah International University, Pakistan
• Treatments: Vitamin D

Criteria

Inclusion Criteria:

• Pregnant women with 07-11 weeks of gestation

• 21 - 40 Years age range

• Pregnant women with high risk for GDM

• history of GDM in their previous pregnancy,

• one or more first-degree relative diagnosed with diabetes mellitus,

• overweight-BMI >25 kg/m2 or obese-BMI >30 kg/m2 at their first antenatal visit

• with a history of polycystic ovarian syndrome.

• Pregnant women with 07-11 weeks of gestation having normal response to 75g OGTT

• Low levels of Vitamin D3 (<30ng/ml)

Exclusion Criteria:

• Women already diagnosed with diabetes mellitus

• Any other systemic disease.

• High risk pregnant women diagnosed with diabetes on the basis of 75g OGTT

• High risk pregnant women with normal vitamin D3 levels (>30ng/ml).