Clinical Trial – High Dose Cholecalciferol and Gestational Diabetes – Gestational Diabetes

This study is to demonstrate dose-dependent relationship between vitamin D supplementation and rates of gestational diabetes.
Detailed Description:
It determines 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.
It 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.

Study Type  : Interventional  (Clinical Trial)
Estimated Enrollment  : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This will be a randomized single-center study with a target study group of 300 women. Women will be followed from enrollment through the remainder of their pregnancy
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Single-Center Study of the Effects of High-Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High-Risk Pregnant Women
Actual Study Start Date  : June 1, 2017
Estimated Primary Completion Date  : June 2020
Estimated Study Completion Date  : June 2020
Contacts
Contact: Samantha Hoffman, MD 612-626-3111 kehoe018@umn.edu
Locations
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Samantha Hoffman, MD    612-626-3111    kehoe018@umn.edu
Sub-Investigator: Laura Hanson, MD
Sub-Investigator: Sarah Westberg, PharmD
ClinicalTrials.gov Identifier: NCT03037593

 

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