High Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High Risk Pregnant Women
Withdrawn before enrolling · Phase 1/Phase 2
Conditions studied: Gestational Diabetes
In brief
Demonstrate dose-dependent relationship between vitamin D supplementation and rates of gestational diabetes.
Key facts
- Study ID
- NCT03037593
- Run by
- University of Minnesota
- People needed
- 0
- Starts
- 2017-06-01
- Expected to finish
- 2020-06-01
- Last updated by the study team
- 2019-11-01
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Minnesota Medical Center — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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