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

A Randomized Single-Center Study of the Effects of High-Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High-Risk Pregnant Women

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

Study Overview

• Status: Withdrawn
• Conditions: Gestational Diabetes
• Intervention / Treatment: Drug: 4000 IU vitamin D3

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 Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 4000 IU vitamin D3 +prenatal vitamin	Drug: 4000 IU vitamin D3; vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin; Other Names: cholecalciferol
No Intervention: Control; standard prenatal vitamin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prescription for insulin or oral hypoglycemic agents	Prescription for insulin or oral hypoglycemic agents	Baseline to Delivery of child
Mode of delivery	Natural or C-Section	Delivery of child
Birth weight	Weight in Kg	Delivery of Child
Apgar score	<7 at 5 minutes	Birth of child to 5 minutes
Shoulder Dystocia		Birth of child

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Samantha Hoffman, MD, University Of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: January 27, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Pregnancy; Gestational Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol
• Other Study ID Numbers: 1611M98781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No