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

Study Overview
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Brief Summary
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Demonstrate dose-dependent relationship between vitamin D supplementation and rates of gestational diabetes.

Detailed Description
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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.

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

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Drug: 4000 IU vitamin D3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Subject established prenatal care no later than the completed 12th week of gestation (12 6/7 weeks) Subject possesses as least one of the following characteristics: BMI greater than or equal to 30 kg/m2 History of gestational diabetes in a prior pregnancy History of infant with birth weight of 4500g or greater Subject is capable of giving informed consent Exclusion Criteria: Age less than 18 years Multiple gestation pregnancies (twins, triplets or greater multiples) Vitamin D deficiency (defined as less than 20 ng/mL) Preexisting diabetes mellitus defined as either: pre-existing diagnosis prior to current pregnancy failure of three-hour glucose tolerance test in first trimester of pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>4000 IU vitamin D3 +prenatal vitamin | Drug: 4000 IU vitamin D3<br>* vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin<br>* Other names: cholecalciferol;|
| No Intervention: Control<br>standard prenatal vitamin | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of gestational diabetes | 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. | Baseline to Delivery of child | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prescription for insulin or oral hypoglycemic agents | Prescription for insulin or oral hypoglycemic agents | Baseline to Delivery of child | 
| Mode of delivery | Natural or C-Section | Delivery of child | 
| Birth weight | Weight in Kg | Delivery of Child | 
| Apgar score | <7 at 5 minutes | Birth of child to 5 minutes | 
| Shoulder Dystocia |  | Birth of child | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Gestational Diabetes