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

Tracking Information

First Received Date ^ICMJE

July 19, 2012

Last Updated Date

August 1, 2012

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01655810 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Vitamin D, Cardiovascular Disease, and African Americans

Official Title ^ICMJE

Vitamin D and Early Markers of Cardiovascular Disease in African Americans

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.

Study Type ^ICMJE

Interventional

Study Phase

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Vitamin D Deficiency
Type 2 Diabetes Mellitus
Cardiovascular Disease

Intervention ^ICMJE

Dietary Supplement: Vitamin D3
Multivitamin containing cholecalciferol 4000 units orally daily

Other Name: Cholecalciferol
Dietary Supplement: Vitamin D3
Multivitamin containing cholecalciferol 600 units orally daily

Other Name: Cholecalciferol
Dietary Supplement: Calcium carbonate
500 mg orally twice daily

Study Arm (s)

Active Comparator: Vitamin D 4000 IU
Interventions:
- Dietary Supplement: Vitamin D3
- Dietary Supplement: Calcium carbonate
Active Comparator: Vitamin D 600 IU
Interventions:
- Dietary Supplement: Vitamin D3
- Dietary Supplement: Calcium carbonate

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

January 2015

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Carlis Bernal-Mizrachi, MD

314-362-0934

cbernal@dom.wustl.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01655810

Other Study ID Numbers ^ICMJE

201102160

Has Data Monitoring Committee

Yes

Responsible Party

Washington University School of Medicine

Study Sponsor ^ICMJE

Washington University School of Medicine

Collaborators ^ICMJE

American Diabetes Association

Investigators ^ICMJE

Principal Investigator:

Carlos Bernal-Mizrachi, MD

Washington University School of Medicine

Information Provided By

Washington University School of Medicine

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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