Study of Vitamin D and Effect on Heart Disease and Insulin Resistance
The Effect of Vitamin D Supplementation on Endothelial Function, Inflammation and Insulin Resistance in HIV
1 other identifier
interventional
45
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 24, 2010
CompletedFirst Posted
Study publicly available on registry
March 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
February 29, 2012
CompletedJuly 14, 2016
June 1, 2016
9 months
March 24, 2010
January 28, 2012
June 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Endothelial Function
Endothelial function measured by flow mediated brachial artery dilation
Baseline and 12 weeks
Secondary Outcomes (1)
Change in Serum 25-hydroxyvitamin D Concentration in Both Groups
Baseline and 12 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants that have been randomized into this arm will receive placebo pills.
Vitamin D 4000 IU
ACTIVE COMPARATORParticipants that have been randomized into this arm will receive Vitamin D 4000 IU (International Units) daily.
Interventions
Eligibility Criteria
You may qualify if:
- HIV infected
- HIV-RNA \< 400 copies/ml at study entry and for 12 wks. prior
- hydroxyvitamin D level \<20
- On a stable anti-retroviral (ARV) regimen for at least 12 weeks prior to study entry
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospitals of Cleveland Case Medical Center
Cleveland, Ohio, 44106, United States
Related Publications (1)
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.
PMID: 22293363DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Grace McComsey, MD
- Organization
- University Hospitals Case Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Peds ID, Rheumatology and Global Health
Study Record Dates
First Submitted
March 24, 2010
First Posted
March 25, 2010
Study Start
January 1, 2010
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
July 14, 2016
Results First Posted
February 29, 2012
Record last verified: 2016-06