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Vitamin D, Cardiovascular Disease, and African Americans

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ClinicalTrials.gov Identifier: NCT01655810
Recruitment Status : Active, not recruiting
First Posted : August 2, 2012
Last Update Posted : February 6, 2018
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Type 2 Diabetes Mellitus Cardiovascular Disease Dietary Supplement: Vitamin D3 Dietary Supplement: Calcium carbonate Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vitamin D and Early Markers of Cardiovascular Disease in African Americans
Study Start Date : July 2012
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline in carotid intima-medial thickness [ Time Frame: 0, 6, and 12 months ]

Secondary Outcome Measures :
  1. Change from baseline in systemic inflammatory markers [ Time Frame: 0, 6, and 12 months ]
  2. Serum calcium [ Time Frame: 0, 1, 3, 6, 9, and 12 months ]
  3. Urinary Calcium [ Time Frame: 0, 1, 3, 6, 9, and 12 months ]


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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01655810


Locations
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
American Diabetes Association
Investigators
Principal Investigator: Carlos Bernal-Mizrachi, MD Washington University School of Medicine

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01655810     History of Changes
Other Study ID Numbers: 201102160
First Posted: August 2, 2012    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018

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