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Completed

NCT Number: NCT01093417

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

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).

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Key information

Conditions

Human Immunodeficiency Virus (HIV) Acquired Immunodeficiency Syndrome Avitaminosis Blood-Borne Infections Communicable Diseases Deficiency Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases Vitamin D Deficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospitals of Cleveland Case Medical Center

Cleveland, Ohio, 44106, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Drug

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

Other names: Calciferol

Placebo

Other

Placebo pills will be administered to enrollees in this arm

Primary outcomes

  1. Change in Endothelial Function

    Time frame: Baseline and 12 weeks

    Endothelial function measured by flow mediated brachial artery dilation

Secondary outcomes

  1. Change in Serum 25-hydroxyvitamin D Concentration in Both Groups

    Time frame: Baseline and 12 weeks

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

The Effect of Vitamin D Supplementation on Endothelial Function, Inflammation and Insulin Resistance in HIV

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 25, 2010
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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