Vitamin D, Cardiovascular Disease, and African Americans

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Vitamin D Deficiency; Cardiovascular Disease
• Interventions: Dietary Supplement: Vitamin D3; Dietary Supplement: Calcium carbonate

• Registration Number: NCT01655810
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-02
• Study Start: 2012-08-13
• Primary Completion: 2018-02-09
• Study Completion: 2018-02-09
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-03
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vitamin D 4000 IU	Calcium carbonate	PO daily
Vitamin D 600 IU	Vitamin D3	PO daily
Vitamin D 600 IU	Calcium carbonate	PO daily
Vitamin D 4000 IU	Vitamin D3	PO daily

Primary Outcome Measures

Name	Time	Method
Change from baseline in carotid intima-medial thickness	0, 6, and 12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States