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

Gestational Diabetes Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03037593
• Other study ID #: 1611M98781
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: June 1, 2017
• Est. completion date: June 2020

Study information

• Verified date: October 2019
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Drug:
• 4000 IU vitamin D3
vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin

Locations

Country	Name	City	State
United States	University of Minnesota Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of gestational diabetes	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.	Baseline to Delivery of child
Secondary	Prescription for insulin or oral hypoglycemic agents	Prescription for insulin or oral hypoglycemic agents	Baseline to Delivery of child
Secondary	Mode of delivery	Natural or C-Section	Delivery of child
Secondary	Birth weight	Weight in Kg	Delivery of Child
Secondary	Apgar score	<7 at 5 minutes	Birth of child to 5 minutes
Secondary	Shoulder Dystocia		Birth of child