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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Grace McComsey, University Hospital Case Medical Center

ClinicalTrials.gov Identifier:

NCT01093417

First received: March 24, 2010

Last updated: June 14, 2016

Last verified: June 2016

History of Changes

Results First Received: January 28, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: Double Blind (Participant, Care Provider, Investigator)
Conditions:	Human Immunodeficiency Virus (HIV) Vitamin D Deficiency HIV Infections
Interventions:	Drug: Vitamin D Other: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	15 participants were randomized to matching placebo for 12 weeks
Vitamin D 4000 IU	30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks

Participant Flow: Overall Study

	Placebo	Vitamin D 4000 IU
STARTED	15	30
COMPLETED	15	29
NOT COMPLETED	0	1

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Placebo	15 participants were randomized to matching placebo for 12 weeks
Vitamin D 4000 IU	30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
Total	Total of all reporting groups

Baseline Measures

	Placebo	Vitamin D 4000 IU	Total
Overall Participants Analyzed [Units: Participants]	15	30	45

Age [Units: Participants]
<=18 years	0	0	0
Between 18 and 65 years	15	30	45
>=65 years	0	0	0

Age [Units: Years] Mean (Standard Deviation)	40 (10)	47 (8)	45 (9)

Gender [Units: Participants]
Female	5	5	10
Male	10	25	35

Region of Enrollment [Units: Participants]
United States	15	30	45

Outcome Measures

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1. Primary:

Change in Endothelial Function [ Time Frame: Baseline and 12 weeks ]

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2. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Grace McComsey, MD
Organization: University Hospitals Case Medical Center
phone: 2168443607
e-mail: gam9@case.edu

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, University Hospital Case Medical Center
ClinicalTrials.gov Identifier:	NCT01093417 History of Changes
Other Study ID Numbers:	11-09-30
Study First Received:	March 24, 2010
Results First Received:	January 28, 2012
Last Updated:	June 14, 2016

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