Clinical Trial â High Dose Cholecalciferol and Gestational Diabetes â 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 Â Â 612-626-3111 Â Â Â kehoe018@umn.edu | |
| Sub-Investigator: Laura Hanson, MD | |
| Sub-Investigator: Sarah Westberg, PharmD | |
| ClinicalTrials.gov Identifier: | NCT03037593 |
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