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Vitamin D, Cardiovascular Disease, and African Americans

This study is currently recruiting participants.
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
History of Changes
  Purpose

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.


Condition Intervention
Vitamin D Deficiency
Type 2 Diabetes Mellitus
Cardiovascular Disease
 Dietary Supplement: Vitamin D3
Dietary Supplement: Calcium carbonate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D and Early Markers of Cardiovascular Disease in African Americans

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change from baseline in carotid intima-medial thickness [ Time Frame: 0, 6, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 86
Study Start Date: July 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vitamin D 4000 IU Dietary Supplement: Vitamin D3
Multivitamin containing cholecalciferol 4000 units orally daily
Other Name: Cholecalciferol
Dietary Supplement: Calcium carbonate
500 mg orally twice daily
Active Comparator: Vitamin D 600 IU Dietary Supplement: Vitamin D3
Multivitamin containing cholecalciferol 600 units orally daily
Other Name: Cholecalciferol
Dietary Supplement: Calcium carbonate
500 mg orally twice daily

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.

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01655810

Contacts
Contact: Carlis Bernal-Mizrachi, MD 314-362-0934 cbernal@dom.wustl.edu

Locations
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Carlos Bernal-Mizrachi, MD     314-362-0934     cbernal@dom.wustl.edu    
Principal Investigator: Carlos Bernal-Mizrachi, MD            
Sponsors and Collaborators
Washington University School of Medicine
American Diabetes Association
Investigators
Principal Investigator: Carlos Bernal-Mizrachi, MD Washington University School of Medicine
  More Information

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01655810     History of Changes
Other Study ID Numbers: 201102160
Study First Received: July 19, 2012
Last Updated: August 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Vitamin D Deficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Calcium Carbonate
 Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Antacids
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013