Vitamin D, Cardiovascular Disease, and African Americans

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Vitamin D and Early Markers of Cardiovascular Disease in African Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01655810
• Other study ID #: 201102160
• Status: Completed
• Phase: N/A
• Start date: August 13, 2012
• Est. completion date: February 9, 2018

Study information

• Verified date: June 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: February 9, 2018
• Est. primary completion date: February 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Type 2 Diabetes Mellitus
• Vitamin D Deficiency

Intervention

Dietary Supplement:
• Vitamin D3
Multivitamin containing cholecalciferol 4000 units orally daily
• Vitamin D3
Multivitamin containing cholecalciferol 600 units orally daily
• Calcium carbonate
500 mg orally twice daily

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in carotid intima-medial thickness		0, 6, and 12 months
Secondary	Change from baseline in systemic inflammatory markers		0, 6, and 12 months
Secondary	Serum calcium		0, 1, 3, 6, 9, and 12 months
Secondary	Urinary Calcium		0, 1, 3, 6, 9, and 12 months