Study of Vitamin D and Effect on Heart Disease and Insulin Resistance

University Hospitals Cleveland Medical Center45 enrolled

Overview

The purpose of this study is to evaluate how Vitamin D affects endothelial function, inflammation, lipids, insulin resistance, vitamin D levels, and parathyroid hormone (PTH).

Randomized placebo controlled trial of vitamin D supplementation in HIV infected subjects with vitamin D deficiency

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

Conditions

Human Immunodeficiency Virus (HIV)Vitamin D Deficiency HIV Infections

Interventions

Vitamin DDRUG

Vitamin D 4000 IU will be administered to enrollees on the active comparator arm

PlaceboOTHER

Placebo pills will be administered to enrollees in this arm

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HIV infected * HIV-RNA \< 400 copies/ml at study entry and for 12 wks. prior * 25-hydroxyvitamin D level \<20 * On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry Exclusion Criteria: * Pregnancy or Breast Feeding * Diabetes * Creatinine Clearance \<50 * Any active infectious or inflammatory condition * aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 within 6 months prior to study entry

Locations (1)

University Hospitals of Cleveland Case Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Change in Endothelial Function

Endothelial function measured by flow mediated brachial artery dilation

Time frame: Baseline and 12 weeks

Secondary Outcomes

Change in Serum 25-hydroxyvitamin D Concentration in Both Groups

Time frame: Baseline and 12 weeks

Data from ClinicalTrials.gov

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