Vitamin D Supplementation and CD4 Count in HIV-Infected Children
1 other identifier
interventional
54
1 country
1
Brief Summary
To find out if vitamin D supplementing can lead to an improvement in immunological status in HIV-infected children as part of routine clinical care
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 hiv
Started Feb 2009
Shorter than P25 for phase_2 hiv
1 active site
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
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedJune 6, 2014
June 1, 2014
8 months
May 29, 2009
June 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in CD4 percent associated with vitamin D supplementation in HIV-infected children
6 months
Secondary Outcomes (4)
Correlation of the actual 25(OH)D and 1,25(OH)D serum levels with CD4 percent
6 months
Change in absolute CD4 count with vitamin D supplementation
6 months
Change in HIV viral load with vitamin D supplementation
6 months
Other measures of vitamin D metabolism including serum calcium, phosphate, alkaline phosphatase, parathyroid hormone (PTH), and urinary calcium/creatinine ratio
0, 3 and 6 months
Study Arms (3)
1
PLACEBO COMPARATOR2
EXPERIMENTAL3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- HIV-infected children as defined by ≥ 2 positive HIV DNA PCRs and/or HIV cultures of blood for children less than 18 months of age, or by positive screening and confirmatory serologic testing in those older than 18 months of age
- Stable HIV disease, defined by the absence of change in HIV clinical or immunologic category during the preceding 6 month period, prior to commencing the study
- Age 3 years through 18 years
- Voluntary informed consent
You may not qualify if:
- Any antiretroviral medication change in the 6 months prior to the study, or any anticipated antiretroviral medication change during the duration of the study
- Active participation in another treatment trial
- Serum calcium \< 2mmol/L at baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Related Publications (1)
Kakalia S, Sochett EB, Stephens D, Assor E, Read SE, Bitnun A. Vitamin D supplementation and CD4 count in children infected with human immunodeficiency virus. J Pediatr. 2011 Dec;159(6):951-7. doi: 10.1016/j.jpeds.2011.06.010. Epub 2011 Aug 4.
PMID: 21820130DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ari Bitnun, MD
The Hospital for Sick Children
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Staff Physician
Study Record Dates
First Submitted
May 29, 2009
First Posted
June 2, 2009
Study Start
February 1, 2009
Primary Completion
October 1, 2009
Study Completion
July 1, 2010
Last Updated
June 6, 2014
Record last verified: 2014-06