Back to resultsHigh Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High Risk Pregnant Women
Primary Purpose
Gestational Diabetes
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
4000 IU vitamin D3
Sponsored by
About this trial
This is an interventional treatment trial for Gestational Diabetes focused on measuring Pregnancy, Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
- Subject established prenatal care no later than the completed 12th week of gestation (12 6/7 weeks)
Subject possesses as least one of the following characteristics:
- BMI greater than or equal to 30 kg/m2
- History of gestational diabetes in a prior pregnancy
- History of infant with birth weight of 4500g or greater
- Subject is capable of giving informed consent
Exclusion Criteria:
- Age less than 18 years
- Multiple gestation pregnancies (twins, triplets or greater multiples)
- Vitamin D deficiency (defined as less than 20 ng/mL)
Preexisting diabetes mellitus defined as either:
- pre-existing diagnosis prior to current pregnancy
- failure of three-hour glucose tolerance test in first trimester of pregnancy
Sites / Locations
- University of Minnesota Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
4000 IU vitamin D3 +prenatal vitamin
standard prenatal vitamin
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Prescription for insulin or oral hypoglycemic agents
Prescription for insulin or oral hypoglycemic agents
Mode of delivery
Natural or C-Section
Birth weight
Weight in Kg
Apgar score
<7 at 5 minutes
Shoulder Dystocia
Full Information
NCT ID
NCT03037593
First Posted
January 27, 2017
Last Updated
October 30, 2019
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT03037593
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Failure to recruit adequate patients
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
Pregnancy, Gestational Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
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)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
4000 IU vitamin D3 +prenatal vitamin
Arm Title
Control
Arm Type
No Intervention
Arm Description
standard prenatal vitamin
Intervention Type
Drug
Intervention Name(s)
4000 IU vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin
Primary Outcome Measure Information:
Title
incidence of gestational diabetes
Description
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.
Time Frame
Baseline to Delivery of child
Secondary Outcome Measure Information:
Title
Prescription for insulin or oral hypoglycemic agents
Description
Prescription for insulin or oral hypoglycemic agents
Time Frame
Baseline to Delivery of child
Title
Mode of delivery
Description
Natural or C-Section
Time Frame
Delivery of child
Title
Birth weight
Description
Weight in Kg
Time Frame
Delivery of Child
Title
Apgar score
Description
<7 at 5 minutes
Time Frame
Birth of child to 5 minutes
Title
Shoulder Dystocia
Time Frame
Birth of child
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Subject established prenatal care no later than the completed 12th week of gestation (12 6/7 weeks)
Subject possesses as least one of the following characteristics:
BMI greater than or equal to 30 kg/m2
History of gestational diabetes in a prior pregnancy
History of infant with birth weight of 4500g or greater
Subject is capable of giving informed consent
Exclusion Criteria:
Age less than 18 years
Multiple gestation pregnancies (twins, triplets or greater multiples)
Vitamin D deficiency (defined as less than 20 ng/mL)
Preexisting diabetes mellitus defined as either:
pre-existing diagnosis prior to current pregnancy
failure of three-hour glucose tolerance test in first trimester of pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samantha Hoffman, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
High Dose Cholecalciferol to Reduce the Incidence of Gestational Diabetes in High Risk Pregnant Women
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