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

Launched by IIMC, RIPHAH INTERNATIONAL UNIVERSITY, PAKISTAN · Nov 17, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether taking vitamin D supplements can help prevent gestational diabetes mellitus (GDM) in pregnant women who are at high risk for this condition. The trial will include 350 women who are between 7 to 11 weeks pregnant, aged 21 to 40, and have low levels of vitamin D. These women may have had GDM in a previous pregnancy, have a family history of diabetes, or are overweight or obese. Participants will be randomly assigned to receive either vitamin D supplements or a placebo (a pill with no active ingredients) for about 4 to 6 weeks.

During the trial, all participants will be tested for GDM at around 24 to 28 weeks of pregnancy using a glucose test. This study aims to find out if vitamin D supplementation can lower the chances of developing GDM based on specific medical criteria. It's important to note that women who already have diabetes or other serious health issues will not be included in the study. If you're interested in participating, you would undergo a screening process to determine if you meet the eligibility criteria.

Gender

FEMALE

Eligibility 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).