Vitamin D Supplementation and CD4 Count in HIV-Infected Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-07-31

Brief Summary

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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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Detailed Description

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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?

Conditions

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HIV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type PLACEBO_COMPARATOR

No supplementation

Intervention Type DRUG

Control

2

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Weekly dose of 5600 IU (800 IU per day)

3

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Weekly dose of 11,200 IU (1600 IU per day)

Interventions

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Vitamin D

Weekly dose of 5600 IU (800 IU per day)

Intervention Type DIETARY_SUPPLEMENT

No supplementation

Control

Intervention Type DRUG

Vitamin D

Weekly dose of 11,200 IU (1600 IU per day)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No