Gestational Diabetes
Conditions
Keywords
Pregnancy, Gestational Diabetes
Brief summary
Demonstrate dose-dependent relationship between vitamin D supplementation and rates of gestational diabetes.
Detailed description
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.
Interventions
vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of gestational diabetes | Baseline to Delivery of child | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prescription for insulin or oral hypoglycemic agents | Baseline to Delivery of child | Prescription for insulin or oral hypoglycemic agents |
| Mode of delivery | Delivery of child | Natural or C-Section |
| Birth weight | Delivery of Child | Weight in Kg |
| Apgar score | Birth of child to 5 minutes | \<7 at 5 minutes |
| Shoulder Dystocia | Birth of child | — |
Countries
United States
Outcome results
None listed