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

• Status: Withdrawn
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota
• Treatments: Cholecalciferol; Vitamin D

Criteria

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