Vitamin D, Cardiovascular Disease, and African Americans
Primary Purpose
Vitamin D Deficiency, Type 2 Diabetes Mellitus, Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D3
Vitamin D3
Calcium carbonate
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency
Eligibility Criteria
Inclusion Criteria:
- African Americans of both genders
- Age 50-70 years
- Type 2 diabetes (A1C < 9.0%), on stable therapy with oral medications, insulin, or a combination
- 25(OH)D level < 20 ng/ml
- BP < 140/90 mmHg; LDL < 140 mg/dl
Exclusion Criteria:
- Pregnancy
- Cardiovascular disease
- Stage 3 or worse chronic kidney disease
- High urine or serum calcium or history of recurrent kidney stones
- Unstable medical conditions or major systemic diseases such as malignancy
Sites / Locations
- Washington University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Vitamin D 4000 IU
Vitamin D 600 IU
Arm Description
PO daily
PO daily
Outcomes
Primary Outcome Measures
Change from baseline in carotid intima-medial thickness
Secondary Outcome Measures
Change from baseline in systemic inflammatory markers
Serum calcium
Urinary Calcium
Full Information
NCT ID
NCT01655810
First Posted
July 19, 2012
Last Updated
June 3, 2020
Sponsor
Washington University School of Medicine
Collaborators
American Diabetes Association
1. Study Identification
Unique Protocol Identification Number
NCT01655810
Brief Title
Vitamin D, Cardiovascular Disease, and African Americans
Official Title
Vitamin D and Early Markers of Cardiovascular Disease in African Americans
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 13, 2012 (Actual)
Primary Completion Date
February 9, 2018 (Actual)
Study Completion Date
February 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
American Diabetes Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
African-Americans have higher rates of cardiovascular disease morbidity and mortality, as well as vitamin D deficiency. Multiple observational studies have demonstrated an increased risk of vitamin D deficiency in African Americans with type 2 diabetes and correlation between cardiovascular disease and vitamin D levels; however, there is a lack of interventional trials exploring this connection. The objective of this proposal is to address the hypothesis that treatment of vitamin D deficiency in African Americans with type 2 diabetes will improve subclinical markers of cardiovascular disease.
Detailed Description
This study will be a double blinded, randomized controlled trial of vitamin D3 supplementation, 4,000 international units per day versus 600 international units per day, for one year to determine the effects on markers of subclinical cardiovascular disease in African Americans with type 2 diabetes and vitamin D deficiency. Outcome assessment will focus on changes in carotid intima-medial thickness (CIMT - ultrasound of the thickness of blood vessels in the neck), as well as markers of systemic inflammation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency, Type 2 Diabetes Mellitus, Cardiovascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D 4000 IU
Arm Type
Active Comparator
Arm Description
PO daily
Arm Title
Vitamin D 600 IU
Arm Type
Active Comparator
Arm Description
PO daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Multivitamin containing cholecalciferol 4000 units orally daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
Cholecalciferol
Intervention Description
Multivitamin containing cholecalciferol 600 units orally daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium carbonate
Intervention Description
500 mg orally twice daily
Primary Outcome Measure Information:
Title
Change from baseline in carotid intima-medial thickness
Time Frame
0, 6, and 12 months
Secondary Outcome Measure Information:
Title
Change from baseline in systemic inflammatory markers
Time Frame
0, 6, and 12 months
Title
Serum calcium
Time Frame
0, 1, 3, 6, 9, and 12 months
Title
Urinary Calcium
Time Frame
0, 1, 3, 6, 9, and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
African Americans of both genders
Age 50-70 years
Type 2 diabetes (A1C < 9.0%), on stable therapy with oral medications, insulin, or a combination
25(OH)D level < 20 ng/ml
BP < 140/90 mmHg; LDL < 140 mg/dl
Exclusion Criteria:
Pregnancy
Cardiovascular disease
Stage 3 or worse chronic kidney disease
High urine or serum calcium or history of recurrent kidney stones
Unstable medical conditions or major systemic diseases such as malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos Bernal-Mizrachi, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Vitamin D, Cardiovascular Disease, and African Americans
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