Vitamin D Supplementation in HIV Youth
Vitamin D Supplementation and HIV-related Complications in Children and Young Adults
1 other identifier
interventional
190
1 country
2
Brief Summary
The purpose of this study is to determine the correct dose of Vitamin D to give to prevent HIV related complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 hiv-infections
Started Dec 2011
Typical duration for phase_2 hiv-infections
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 27, 2012
CompletedFirst Posted
Study publicly available on registry
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedResults Posted
Study results publicly available
February 6, 2018
CompletedMarch 8, 2018
February 1, 2018
4.7 years
January 27, 2012
October 24, 2017
February 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 )
6 months
Secondary Outcomes (1)
Changes in Vitamin D Binding Protein (VDBP)
6 months
Study Arms (2)
HIV + Young Adults
ACTIVE COMPARATORAll 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 - Controls
ACTIVE COMPARATORHIV 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)
Interventions
18,000 IU per month
60,000 IU per month(medium dose) or 120,000 IU/month(high dose)
Eligibility Criteria
You may qualify if:
- Ages 8-25
- Documented HIV-1 infection
- On stable antiretroviral therapy for \> 3 months
- Cumulative antiretroviral therapy of at least 6 months
- (OH)D level \< 30 ng/ml at screening
You may not qualify if:
- \> 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospitals Cleveland Medical Centerlead
- Emory Universitycollaborator
Study Sites (2)
Emory Children's Center
Atlanta, Georgia, 30322, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
Related Publications (3)
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.
PMID: 28994661DERIVEDEckard 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.
PMID: 28327462DERIVEDHileman 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.
PMID: 26890209DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Limitations to this study include the lack of adherence measures to study drug such as pill counts and the small sample size.
Results Point of Contact
- Title
- Dr Grace McComsey
- Organization
- University Hospitals Cleveland Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Grace McComsey, MD, FIDSA
University Hospitals Cleveland Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pediatrics and Medicine, Chief Pediatric Infectious Diseases, Rheumatology and Global Health
Study Record Dates
First Submitted
January 27, 2012
First Posted
February 1, 2012
Study Start
December 1, 2011
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
March 8, 2018
Results First Posted
February 6, 2018
Record last verified: 2018-02