Clinical trial NCT03037593: High Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High Risk Pregnant Women
Official title: A Randomized Single-Center Study of the Effects of High-Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High-Risk Pregnant Women
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Gestational Diabetes
Keywords: Pregnancy
Gestational Diabetes
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-01-31
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: incidence of gestational diabetes
timeFrame: Baseline to Delivery of child
Secondary outcomes:
measure: Prescription for insulin or oral hypoglycemic agents
timeFrame: Baseline to Delivery of child
measure: Mode of delivery
timeFrame: Delivery of child
measure: Birth weight
timeFrame: Delivery of Child
measure: Apgar score
timeFrame: Birth of child to 5 minutes
measure: Shoulder Dystocia
timeFrame: Birth of child
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Samantha Hoffman, MD
role: PRINCIPAL_INVESTIGATOR
References: