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Vitamin D Supplementation and CD4 Count in HIV-Infected Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00911664
First Posted: June 2, 2009
Last Update Posted: June 6, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ari Bitnun, The Hospital for Sick Children
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Ari Bitnun, 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 ]

Secondary Outcome Measures:
  • Correlation of the actual 25(OH)D and 1,25(OH)D serum levels with CD4 percent [ Time Frame: 6 months ]
  • Change in absolute CD4 count with vitamin D supplementation [ Time Frame: 6 months ]
  • Change in HIV viral load with vitamin D supplementation [ Time Frame: 6 months ]
  • 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 ]

Enrollment: 54
Study Start Date: February 2009
Study Completion Date: July 2010
Primary Completion Date: October 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:

  1. Does vitamin D supplementation lead to a change in CD4 percent (CD4 count) in HIV-infected children?
  2. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ari Bitnun, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00911664     History of Changes
Other Study ID Numbers: 1000012867
First Submitted: May 29, 2009
First Posted: June 2, 2009
Last Update Posted: June 6, 2014
Last Verified: June 2014

Keywords provided by Ari Bitnun, The Hospital for Sick Children:
Vitamin D
HIV-Infected children
CD4 count

Additional relevant MeSH terms:
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents


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