Vitamin D Supplementation in HIV Youth

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ClinicalTrials.gov Identifier: NCT01523496

Recruitment Status : Completed

First Posted : February 1, 2012

Results First Posted : February 6, 2018

Last Update Posted : March 8, 2018

Sponsor:

Collaborator:

Emory University

Information provided by (Responsible Party):

Grace McComsey, University Hospitals Cleveland Medical Center

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	HIV Infections
Interventions:	Drug: Vitamin D control dose Drug: Vitamin D supplementation-

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
HIV+ With Vit D Supplementation	HIV-infected adults who were supplemented with vit D ( medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month ) were combined into the supplementation group and compared to the standard control vitamin D dose
HIV+ Young Adults With Vitamin D Control Dose	HIV+ receiving Vitamin D low dose: 18,000 IU per month
HIV - With Vitamin D Supplementation	HIV-uninfected adults who were supplemented with vitamin D: a medium dose of 60,000 IU per month or a higher dose of 120,000 IU/month.
HIV - With Vitamin D Control Dose	HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month

Participant Flow: Overall Study

	HIV+ With Vit D Supplementation	HIV+ Young Adults With Vitamin D Control Dose	HIV - With Vitamin D Supplementation	HIV - With Vitamin D Control Dose
STARTED	66 ^[1]	36	58 ^[1]	30
COMPLETED	56	32	46	27
NOT COMPLETED	10	4	12	3

^[1]	The supplementation group includes medium and high dose vitamin D supplementation

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.
A total of 190 subjects were enrolled, including 102 HIV-infected subjects: 66 on vitamin D supplementation dose, 36 on vitamin D control dose and 88 healthy controls: 58 on vitamin D supplementation dose, 30 on vitamin D control dose. By design, groups were well matched for age, sex and race.

Reporting Groups

	Description
HIV+ With Vit D Supplementation	HIV-infected adults who were supplemented with vit D ( medium dose: 60,000 IU per month or vitamin D high dose: 120,000 IU/month ) were combined into the supplementation group and compared to the standard control vitamin D dose
HIV+ Young Adults With Vitamin D Control Dose	HIV+ receiving Vitamin D low dose: 18,000 IU per month
HIV - With Vitamin D Supplementation	HIV-uninfected adults who were supplemented with vitamin D: a medium dose of 60,000 IU per month or a higher dose of 120,000 IU/month.
HIV - With Vitamin D Control Dose	HIV uninfected controls receiving Vitamin D low dose: 18,000 IU per month
Total	Total of all reporting groups

Baseline Measures

	HIV+ With Vit D Supplementation	HIV+ Young Adults With Vitamin D Control Dose	HIV - With Vitamin D Supplementation	HIV - With Vitamin D Control Dose	Total
Overall Participants Analyzed [Units: Participants]	66	36	58	30	190

Age [Units: Years] Median (Inter-Quartile Range)	20.9 (17.0 to 23.6)	19.9 (15.9 to 21.6)	19.6 (14.4 to 23.2)	18.4 (14.4 to 22.2)	19.9 (15.5 to 23.0)

Sex: Female, Male [Units: Participants] Count of Participants
Female	22 33.3%	15 41.7%	20 34.5%	15 50.0%	72 37.9%
Male	44 66.7%	21 58.3%	38 65.5%	15 50.0%	118 62.1%

Race (NIH/OMB) [Units: Participants] Count of Participants
American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Black or African American	57 86.4%	34 94.4%	47 81.0%	29 96.7%	167 87.9%
White	9 13.6%	2 5.6%	11 19.0%	1 3.3%	23 12.1%
More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

Region of Enrollment [Units: Participants]
United States	66	36	58	30	190

Outcome Measures

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1. Primary:

Changes in Serum 25(OH)D3 Levels [ Time Frame: 6 months ]

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2. Secondary:

Changes in Vitamin D Binding Protein (VDBP) [ Time Frame: 6 months ]

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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
Limitations to this study include the lack of adherence measures to study drug such as pill counts and the small sample size.

More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:

Name/Title: Dr Grace McComsey
Organization: University Hospitals Cleveland Medical Center
phone: 216-844-2739
e-mail: Grace.McComsey@UHhospitals.org

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

Eckard AR, Rosebush JC, O'Riordan MA, Graves CC, Alexander A, Grover AK, Lee ST, Habib JG, Ruff JH, Chahroudi A, McComsey GA. Neurocognitive dysfunction in HIV-infected youth: investigating the relationship with immune activation. Antivir Ther. 2017;22(8):669-680. doi: 10.3851/IMP3157.

Hileman CO, Overton ET, McComsey GA. Vitamin D and bone loss in HIV. Curr Opin HIV AIDS. 2016 May;11(3):277-84. doi: 10.1097/COH.0000000000000272. Review.

Responsible Party:	Grace McComsey, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier:	NCT01523496 History of Changes
Other Study ID Numbers:	09-11-06
First Submitted:	January 27, 2012
First Posted:	February 1, 2012
Results First Submitted:	October 24, 2017
Results First Posted:	February 6, 2018
Last Update Posted:	March 8, 2018

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