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Completed

NCT Number: NCT00911664

Vitamin D Supplementation and CD4 Count in HIV-Infected 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

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Key information

Conditions

HIV

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

Weekly dose of 5600 IU (800 IU per day)

No supplementation

Drug

Control

Primary outcomes

  1. Change in CD4 percent associated with vitamin D supplementation in HIV-infected children

    Time frame: 6 months

Secondary outcomes

  1. Correlation of the actual 25(OH)D and 1,25(OH)D serum levels with CD4 percent

    Time frame: 6 months

  2. Change in absolute CD4 count with vitamin D supplementation

    Time frame: 6 months

  3. Change in HIV viral load with vitamin D supplementation

    Time frame: 6 months

  4. 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

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Jun 2, 2009
Registry last updated
Jun 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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