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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: January 27, 2017
• First Posted Date: January 31, 2017
• Last Update Posted Date: November 1, 2019
• Actual Study Start Date: June 1, 2017
• Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 15, 2017)

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.

Original Primary Outcome Measures (submitted: January 30, 2017)

incidence of gestational dibetes [ 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.

Current Secondary Outcome Measures (submitted: January 30, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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 Type: Interventional
• Study Phase: Phase 1; Phase 2

Study Design

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

• Condition: Gestational Diabetes

Intervention

Drug: 4000 IU vitamin D3

vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin

Other Name: cholecalciferol

Study Arms

• Experimental: Intervention
  4000 IU vitamin D3 +prenatal vitamin
  Intervention: Drug: 4000 IU vitamin D3
• No Intervention: Control
  standard prenatal vitamin

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: May 1, 2019): 0
• Original Estimated Enrollment (submitted: January 30, 2017): 300
• Estimated Study Completion Date: June 2020
• Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03037593
• Other Study ID Numbers: 1611M98781
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: University of Minnesota
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Minnesota
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Minnesota
• Verification Date: October 2019