Vitamin D, Cardiovascular Disease, and African Americans

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Washington University School of Medicine
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01655810
First received: July 19, 2012
Last updated: August 1, 2012
Last verified: July 2012

July 19, 2012
August 1, 2012
July 2012
January 2015   (final data collection date for primary outcome measure)
Change from baseline in carotid intima-medial thickness [ Time Frame: 0, 6, and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01655810 on ClinicalTrials.gov Archive Site
  • Change from baseline in systemic inflammatory markers [ Time Frame: 0, 6, and 12 months ] [ Designated as safety issue: No ]
  • Serum calcium [ Time Frame: 0, 1, 3, 6, 9, and 12 months ] [ Designated as safety issue: Yes ]
  • Urinary Calcium [ Time Frame: 0, 1, 3, 6, 9, and 12 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Vitamin D, Cardiovascular Disease, and African Americans
Vitamin D and Early Markers of Cardiovascular Disease in African Americans

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Vitamin D Deficiency
  • Type 2 Diabetes Mellitus
  • Cardiovascular Disease
  • Dietary Supplement: Vitamin D3
    Multivitamin containing cholecalciferol 4000 units orally daily
    Other Name: Cholecalciferol
  • Dietary Supplement: Vitamin D3
    Multivitamin containing cholecalciferol 600 units orally daily
    Other Name: Cholecalciferol
  • Dietary Supplement: Calcium carbonate
    500 mg orally twice daily
  • Active Comparator: Vitamin D 4000 IU
    Interventions:
    • Dietary Supplement: Vitamin D3
    • Dietary Supplement: Calcium carbonate
  • Active Comparator: Vitamin D 600 IU
    Interventions:
    • Dietary Supplement: Vitamin D3
    • Dietary Supplement: Calcium carbonate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
86
January 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
50 Years to 70 Years
No
Contact: Carlis Bernal-Mizrachi, MD 314-362-0934 cbernal@dom.wustl.edu
United States
 
NCT01655810
201102160
Yes
Washington University School of Medicine
Washington University School of Medicine
American Diabetes Association
Principal Investigator: Carlos Bernal-Mizrachi, MD Washington University Early Recognition Center
Washington University School of Medicine
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP