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

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ClinicalTrials.gov Identifier: NCT01093417

Recruitment Status : Completed

First Posted : March 25, 2010

Results First Posted : February 29, 2012

Last Update Posted : July 14, 2016

Sponsor:

Information provided by (Responsible Party):

Grace McComsey, University Hospitals Cleveland Medical Center

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Human Immunodeficiency Virus (HIV) Vitamin D Deficiency HIV Infections	Drug: Vitamin D Other: Placebo	Phase 2

Detailed Description:

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

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	45 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Official Title:	The Effect of Vitamin D Supplementation on Endothelial Function, Inflammation and Insulin Resistance in HIV
Study Start Date :	January 2010
Actual Primary Completion Date :	October 2010
Actual Study Completion Date :	October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS Vitamin D

Drug Information available for: Vitamin D

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo Participants that have been randomized into this arm will receive placebo pills.	Other: Placebo Placebo pills will be administered to enrollees in this arm
Active Comparator: Vitamin D 4000 IU Participants that have been randomized into this arm will receive Vitamin D 4000 IU (International Units) daily.	Drug: Vitamin D Vitamin D 4000 IU will be administered to enrollees on the active comparator arm Other Name: Calciferol

Outcome Measures

Primary Outcome Measures :

Change in Endothelial Function [ Time Frame: Baseline and 12 weeks ]
Endothelial function measured by flow mediated brachial artery dilation

Secondary Outcome Measures :

Change in Serum 25-hydroxyvitamin D Concentration in Both Groups [ Time Frame: Baseline and 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01093417

Locations


United States, Ohio
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

University Hospitals Cleveland Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Longenecker CT, Hileman CO, Carman TL, Ross AC, Seydafkan S, Brown TT, Labbato DE, Storer N, Tangpricha V, McComsey GA. Vitamin D supplementation and endothelial function in vitamin D deficient HIV-infected patients: a randomized placebo-controlled trial. Antivir Ther. 2012;17(4):613-21. doi: 10.3851/IMP1983. Epub 2011 Nov 17.


Responsible Party:	Grace McComsey, Chief, Peds ID, Rheumatology and Global Health, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier:	NCT01093417 History of Changes
Other Study ID Numbers:	11-09-30
First Posted:	March 25, 2010 Key Record Dates
Results First Posted:	February 29, 2012
Last Update Posted:	July 14, 2016
Last Verified:	June 2016

Keywords provided by Grace McComsey, University Hospitals Cleveland Medical Center:


Vitamin D Human Immunodeficiency Virus (HIV) Complementary Therapies

Additional relevant MeSH terms:


HIV Infections Immunologic Deficiency Syndromes Insulin Resistance Acquired Immunodeficiency Syndrome Vitamin D Deficiency Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immune System Diseases Hyperinsulinism Glucose Metabolism Disorders	Metabolic Diseases Slow Virus Diseases Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Vitamins Vitamin D Ergocalciferols Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents

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