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

• ClinicalTrials.gov Identifier: NCT03037593
• Recruitment Status: Withdrawn
• First Posted: January 31, 2017
• Last Update Posted: November 1, 2019
• Sponsor: University of Minnesota
• Information provided by (Responsible Party): University of Minnesota

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Gestational Diabetes	Drug: 4000 IU vitamin D3	Phase 1; Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• 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
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: June 1, 2017
• Estimated Primary Completion Date: June 2020
• Estimated Study Completion Date: June 2020

Arms and Interventions

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 Name: cholecalciferol
No Intervention: Control; standard prenatal vitamin

Outcome Measures

Primary Outcome Measures :

1. incidence of gestational diabetes [ Time Frame: 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 :

1. Prescription for insulin or oral hypoglycemic agents [ Time Frame: Baseline to Delivery of child ]
   Prescription for insulin or oral hypoglycemic agents
2. Mode of delivery [ Time Frame: Delivery of child ]
   Natural or C-Section
3. Birth weight [ Time Frame: Delivery of Child ]
   Weight in Kg
4. Apgar score [ Time Frame: Birth of child to 5 minutes ]
   <7 at 5 minutes
5. Shoulder Dystocia [ Time Frame: Birth of child ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Minnesota

University of Minnesota Medical Center

Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota

Investigators

• Principal Investigator: Samantha Hoffman, MD; University of Minnesota

More Information

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT03037593
• Other Study ID Numbers: 1611M98781
• First Posted: January 31, 2017
• Last Update Posted: November 1, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Minnesota:

Pregnancy; Gestational Diabetes

Additional relevant MeSH terms:

Diabetes, Gestational; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Vitamin D; Cholecalciferol; Vitamins; Micronutrients; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents