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

June 14, 2016 updated by: Grace McComsey, University Hospitals Cleveland Medical Center

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • Calciferol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Endothelial Function
Time Frame: Baseline and 12 weeks
Endothelial function measured by flow mediated brachial artery dilation
Baseline and 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 24, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Estimate)

July 14, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-09-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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