Vitamin D Supplementation and CD4 Count in HIV-Infected Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ari Bitnun, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00911664
First received: May 29, 2009
Last updated: June 5, 2014
Last verified: June 2014
  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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Staff Physician, 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: June 5, 2014
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 July 23, 2014