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Failure to recruit adequate patients
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Demonstrate dose-dependent relationship between vitamin D supplementation and rates of 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 4000 IU vitamin D3 +prenatal vitamin |
|
| Control | No Intervention | standard prenatal vitamin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4000 IU vitamin D3 | Drug | vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin |
|
| 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 |
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Samantha Hoffman, MD | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55455 | United States |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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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
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| 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 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |