Vitamin D Supplementation and CD4 Count in HIV-Infected Children

June 5, 2014 updated by: Ari Bitnun, The Hospital for Sick Children
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Dietary supplement: Vitamin D
Weekly dose of 5600 IU (800 IU per day)
Dietary supplement: Vitamin D
Weekly dose of 11,200 IU (1600 IU per day)
Placebo Comparator: 1
Drug: No supplementation
Control
Experimental: 3
Dietary supplement: Vitamin D
Weekly dose of 5600 IU (800 IU per day)
Dietary supplement: Vitamin D
Weekly dose of 11,200 IU (1600 IU per day)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in CD4 percent associated with vitamin D supplementation in HIV-infected children
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation of the actual 25(OH)D and 1,25(OH)D serum levels with CD4 percent
Time Frame: 6 months
6 months
Change in absolute CD4 count with vitamin D supplementation
Time Frame: 6 months
6 months
Change in HIV viral load with vitamin D supplementation
Time Frame: 6 months
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
0, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Ari Bitnun, MD, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

June 1, 2009

First Posted (Estimate)

June 2, 2009

Study Record Updates

Last Update Posted (Estimate)

June 6, 2014

Last Update Submitted That Met QC Criteria

June 5, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000012867

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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