Vitamin D Supplementation and CD4 Count in HIV-Infected Children
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by The Hospital for Sick Children.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
The Hospital for Sick Children
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00911664
First received: May 29, 2009
Last updated: November 11, 2009
Last verified: November 2009
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
HIV |
Dietary Supplement: Vitamin D Drug: No supplementation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Vitamin D Supplementation and CD4 Count in HIV-Infected Children |
Resource links provided by NLM:
Further study details as provided by The Hospital for Sick Children:
Primary Outcome Measures:
- Change in CD4 percent associated with vitamin D supplementation in HIV-infected children [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Correlation of the actual 25(OH)D and 1,25(OH)D serum levels with CD4 percent [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in absolute CD4 count with vitamin D supplementation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in HIV viral load with vitamin D supplementation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Other measures of vitamin D metabolism including serum calcium, phosphate, alkaline phosphatase, parathyroid hormone (PTH), and urinary calcium/creatinine ratio [ Time Frame: 0, 3 and 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 54 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: No supplementation
Control
|
| Experimental: 2 |
Dietary Supplement: Vitamin D
Weekly dose of 5600 IU (800 IU per day)
|
| Experimental: 3 |
Dietary Supplement: Vitamin D
Weekly dose of 11,200 IU (1600 IU per day)
|
Detailed Description:
The objective of this study is to determine the impact of vitamin D on immunological status in HIV-infected children as measured by CD4 count (CD4 percent). We will determine if vitamin D supplementation leads to a measurable change in CD4 count (CD4 percent) in HIV-infected children in the context of routine clinical care.
Specific study questions are:
- Does vitamin D supplementation lead to a change in CD4 percent (CD4 count) in HIV-infected children?
- Do the serum levels of the active form of vitamin D [1, 25(OH)2D and 25(OH)D] correlate with CD4 percent (CD4 count) in HIV-infected children?
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911664
Locations
| Canada, Ontario | |
| The Hospital for Sick Children | |
| Toronto, Ontario, Canada, M5G 1X8 | |
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
| Principal Investigator: | Ari Bitnun, MD | The Hospital for Sick Children |
More Information
No publications provided by The Hospital for Sick Children
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ari Bitnun, The Hospital for Sick Children |
| ClinicalTrials.gov Identifier: | NCT00911664 History of Changes |
| Other Study ID Numbers: | 1000012867 |
| Study First Received: | May 29, 2009 |
| Last Updated: | November 11, 2009 |
| Health Authority: | Canada: Health Canada |
Keywords provided by The Hospital for Sick Children:
|
Vitamin D HIV-Infected children CD4 count |
Additional relevant MeSH terms:
|
Vitamin D Ergocalciferols Vitamins Bone Density Conservation Agents |
Physiological Effects of Drugs Pharmacologic Actions Micronutrients Growth Substances |
ClinicalTrials.gov processed this record on May 19, 2013