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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease; Type 2 Diabetes Mellitus; Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D3; Dietary supplement: Vitamin D3; Dietary supplement: Calcium carbonate

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
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vitamin D 4000 IU; PO daily	Dietary supplement: Vitamin D3; Multivitamin containing cholecalciferol 4000 units orally daily; Other Names: Cholecalciferol; Dietary supplement: Vitamin D3; Multivitamin containing cholecalciferol 600 units orally daily; Other Names: Cholecalciferol; Dietary supplement: Calcium carbonate; 500 mg orally twice daily
Active Comparator: Vitamin D 600 IU; PO daily	Dietary supplement: Vitamin D3; Multivitamin containing cholecalciferol 4000 units orally daily; Other Names: Cholecalciferol; Dietary supplement: Vitamin D3; Multivitamin containing cholecalciferol 600 units orally daily; Other Names: Cholecalciferol; Dietary supplement: Calcium carbonate; 500 mg orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in carotid intima-medial thickness	0, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in systemic inflammatory markers	0, 6, and 12 months
Serum calcium	0, 1, 3, 6, 9, and 12 months
Urinary Calcium	0, 1, 3, 6, 9, and 12 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: American Diabetes Association
• Investigators: Principal Investigator: Carlos Bernal-Mizrachi, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2012
• Primary Completion (Actual): February 9, 2018
• Study Completion (Actual): February 9, 2018

Study Registration Dates

• First Submitted: July 19, 2012
• First Submitted That Met QC Criteria: August 1, 2012
• First Posted (Estimate): August 2, 2012

Study Record Updates

• Last Update Posted (Actual): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 3, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Vitamin D Deficiency; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Antacids; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols; Calcium Carbonate
• Other Study ID Numbers: 201102160