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

University of Minnesota (UMN)

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Gestational Diabetes

Treatments: Drug: 4000 IU vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT03037593

1611M98781

Details and patient eligibility

About

Demonstrate dose-dependent relationship between vitamin D supplementation and rates of gestational diabetes.

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Intervention

Experimental group

Description:

4000 IU vitamin D3 +prenatal vitamin

Treatment:

Drug: 4000 IU vitamin D3

Control

No Intervention group

Description:

standard prenatal vitamin