Vitamin D, Cardiovascular Disease, and African Americans

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-13

Study Completion Date

2018-02-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vitamin D, Glucose Control and Insulin Sensitivity in African-Americans

NCT00784511

Type 2 Diabetes

COMPLETED PHASE2

Effect of Vitamin D3 on Vascular Function

NCT00948298

Vitamin D Deficiency

COMPLETED NA

Vitamin D, Insulin Resistance, and Cardiovascular Disease

NCT00736632

Vitamin D Deficiency Insulin Resistance Type 2 Diabetes Mellitus +2 more

COMPLETED NA

Effects of Vitamin D on Cardiovascular Health in Black Women

NCT05656742

Vitamin d Deficiency

COMPLETED NA

Impact of Vitamin D on Diabetic Kidney Disease in African Americans

NCT01214356

Diabetic Kidney Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vitamin D Deficiency Type 2 Diabetes Mellitus Cardiovascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.