NCT03037593

High Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High Risk Pregnant Women

A Randomized Single-Center Study of the Effects of High-Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High-Risk Pregnant Women

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Demonstrate dose-dependent relationship between vitamin D supplementation and rates of gestational diabetes.

Detailed description

Determine the effect of increased vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin) on the incidence of gestational diabetes compared to a standard prenatal vitamin among pregnant women at high risk for gestational diabetes. Explore the effect of increased vitamin D supplementation (4000 IU daily + prenatal vitamin), compared to a standard prenatal vitamin, on glycemic control, need for oral hypoglycemic agents and/or insulin, and delivery outcomes among the subset of women who develop gestational diabetes.

Conditions

• Gestational Diabetes

Interventions

Type	Name	Description
DRUG	4000 IU vitamin D3	vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin

Timeline

• Start date: 2017-06-01
• Primary completion: 2020-06-01
• Completion: 2020-06-01
• First posted: 2017-01-31
• Last updated: 2019-11-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study