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NCT Number: NCT01655810

Vitamin D, Cardiovascular Disease, and 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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Cardiovascular Disease Cardiovascular Diseases Deficiency Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Type 2 Diabetes Mellitus

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Dietary Supplement

Multivitamin containing cholecalciferol 4000 units orally daily

Other names: Cholecalciferol

Calcium Carbonate

Dietary Supplement

500 mg orally twice daily

Primary outcomes

  1. Change from baseline in carotid intima-medial thickness

    Time frame: 0, 6, and 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

Vitamin D and Early Markers of Cardiovascular Disease in African Americans

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2012
Registry last updated
Jun 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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