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

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ClinicalTrials.gov Identifier: NCT03037593
Recruitment Status : Recruiting
First Posted : January 31, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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



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 ]


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03037593


Contacts
Contact: Samantha Hoffman, MD 612-626-3111 kehoe018@umn.edu

Locations
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Samantha Hoffman, MD    612-626-3111    kehoe018@umn.edu   
Sub-Investigator: Laura Hanson, MD         
Sub-Investigator: Sarah Westberg, PharmD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Samantha Hoffman, MD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03037593     History of Changes
Other Study ID Numbers: VITD
First Posted: January 31, 2017    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
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 - Clinical and Translational Science Institute:
Pregnancy
Gestational Diabetes

Additional relevant MeSH terms:
Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents