High Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High Risk Pregnant Women
Status: | Recruiting |
---|---|
Conditions: | Diabetes |
Therapuetic Areas: | Endocrinology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/31/2017 |
Start Date: | June 1, 2017 |
End Date: | June 2020 |
Contact: | Samantha Hoffman, MD |
Email: | kehoe018@umn.edu |
Phone: | 612-626-3111 |
A Randomized Single-Center Study of the Effects of High-Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High-Risk Pregnant Women
Demonstrate dose-dependent relationship between vitamin D supplementation and rates of
gestational diabetes.
gestational diabetes.
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.
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.
Inclusion Criteria:
1. Women who are currently pregnant and receiving prenatal care at the Women's Health
Specialists Clinic (University of Minnesota Physicians) from either MD/DO or CNM
providers
2. Subject established prenatal care no later than the completed 12th week of gestation
(12 6/7 weeks)
3. Subject possesses as least one of the following characteristics:
1. BMI greater than or equal to 30 kg/m2
2. History of gestational diabetes in a prior pregnancy
3. History of infant with birth weight of 4500g or greater
4. Subject is capable of giving informed consent
Exclusion Criteria:
1. Age less than 18 years
2. Multiple gestation pregnancies (twins, triplets or greater multiples)
3. Vitamin D deficiency (defined as less than 20 ng/mL)
4. Preexisting diabetes mellitus defined as either:
1. pre-existing diagnosis prior to current pregnancy
2. failure of three-hour glucose tolerance test in first trimester of pregnancy
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