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Vitamin D Supplementation in HIV Youth

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin D control dose
Vitamin D supplementation-
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, Vitamin D Deficiency

Eligibility Criteria

8 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Ages 8-25
  • Documented HIV-1 infection
  • On stable antiretroviral therapy for > 3 months
  • Cumulative antiretroviral therapy of at least 6 months
  • 25(OH)D level < 30 ng/ml at screening

Exclusion Criteria:

  • > 400 IU daily regular vitamin D intake
  • Parathyroid/calcium disorders
  • Active malignancy
  • Pregnancy/intent to become pregnant/breastfeeding
  • Chronic infectious/inflammatory conditions
  • Creatinine clearance < 50 ml/min
  • Hemoglobin < 9.0 g/dL
  • Aspartate aminotransferase and alanine aminotransferase > 2.5 upper limit of normal
  • Diabetes requiring hypoglycemic agents
  • Known coronary artery disease
  • Inability to swallow pills

Sites / Locations

  • Emory Children's Center
  • University Hospitals Case Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

HIV + Young Adults

HIV - Controls

Arm Description

All will be HIV+ and receiving randomized dose of vitamin D control dose (low dose) or supplementation dose (vitamin D medium dose or vitamin D high dose)

HIV negative controls will be receiving randomized Vitamin D doses: control vitamin D dose (low dose) or vitamin D supplementation dose (vitamin D medium dose or vitamin D high dose)

Outcomes

Primary Outcome Measures

Changes in Serum 25(OH)D3 Levels
Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month )

Secondary Outcome Measures

Changes in Vitamin D Binding Protein (VDBP)
Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation.

Full Information

First Posted
January 27, 2012
Last Updated
February 5, 2018
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Emory University
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1. Study Identification

Unique Protocol Identification Number
NCT01523496
Brief Title
Vitamin D Supplementation in HIV Youth
Official Title
Vitamin D Supplementation and HIV-related Complications in Children and Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Emory University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.
Detailed Description
The purpose of the this study was to compare control dose of vitamin D (low dose of 600 IU/d) to supplementation dose (medium dose of 2000 IU/d or higher doses of vitamin D of 4000 IU/d) on HIV-related comorbidities including immune activation, inflammation, cardiovascular diseases, and metabolic complications in HIV-infected youth.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, Vitamin D Deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
190 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV + Young Adults
Arm Type
Active Comparator
Arm Description
All will be HIV+ and receiving randomized dose of vitamin D control dose (low dose) or supplementation dose (vitamin D medium dose or vitamin D high dose)
Arm Title
HIV - Controls
Arm Type
Active Comparator
Arm Description
HIV negative controls will be receiving randomized Vitamin D doses: control vitamin D dose (low dose) or vitamin D supplementation dose (vitamin D medium dose or vitamin D high dose)
Intervention Type
Drug
Intervention Name(s)
Vitamin D control dose
Other Intervention Name(s)
25(OH)D3 low dose
Intervention Description
18,000 IU per month
Intervention Type
Drug
Intervention Name(s)
Vitamin D supplementation-
Other Intervention Name(s)
25(OH)D3 medium dose or 25(OH)high dose
Intervention Description
60,000 IU per month(medium dose) or 120,000 IU/month(high dose)
Primary Outcome Measure Information:
Title
Changes in Serum 25(OH)D3 Levels
Description
Evaluate the dose-related efficacy of correction of Vitamin D deficiency for 25(OH)D3 levels in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral Vitamin D supplementation: control dose (18,000 IU per month) or supplemented dose (medium 60,000IU per month or high dose 120,000IU/month )
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in Vitamin D Binding Protein (VDBP)
Description
Evaluate the dose-related efficacy of vitamin D binding Protein in levels in the blood in a group of HIV-infected children and young adults and a matched healthy control group in a randomized controlled study of different dosing regimens of oral vitamin D supplementation.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Ages 8-25 Documented HIV-1 infection On stable antiretroviral therapy for > 3 months Cumulative antiretroviral therapy of at least 6 months 25(OH)D level < 30 ng/ml at screening Exclusion Criteria: > 400 IU daily regular vitamin D intake Parathyroid/calcium disorders Active malignancy Pregnancy/intent to become pregnant/breastfeeding Chronic infectious/inflammatory conditions Creatinine clearance < 50 ml/min Hemoglobin < 9.0 g/dL Aspartate aminotransferase and alanine aminotransferase > 2.5 upper limit of normal Diabetes requiring hypoglycemic agents Known coronary artery disease Inability to swallow pills
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grace McComsey, MD, FIDSA
Organizational Affiliation
University Hospitals Cleveland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Children's Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28994661
Citation
Eckard AR, O'Riordan MA, Rosebush JC, Lee ST, Habib JG, Ruff JH, Labbato D, Daniels JE, Uribe-Leitz M, Tangpricha V, Chahroudi A, McComsey GA. Vitamin D supplementation decreases immune activation and exhaustion in HIV-1-infected youth. Antivir Ther. 2018;23(4):315-324. doi: 10.3851/IMP3199.
Results Reference
derived
PubMed Identifier
28327462
Citation
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.
Results Reference
derived
PubMed Identifier
26890209
Citation
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.
Results Reference
derived

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Vitamin D Supplementation in HIV Youth

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