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

Phase 1

Withdrawn

• Conditions: Gestational Diabetes
• Interventions: Drug: 4000 IU vitamin D3

• Registration Number: NCT03037593
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-01-31
• Study Start: 2017-06-01
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-30
• Last Update Posted: 2019-11-01
• Primary Completion: 2020-06
• Study Completion: 2020-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	4000 IU vitamin D3	4000 IU vitamin D3 +prenatal vitamin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Apgar score	Birth of child to 5 minutes	\<7 at 5 minutes
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
Shoulder Dystocia	Birth of child

Trial Locations

Locations (1)

University of Minnesota Medical Center; 🇺🇸 Minneapolis, Minnesota, United States