Vitamin D Supplementation and CD4 Count in HIV-Infected Children

Phase 2

Completed

• Conditions: HIV
• Interventions: Drug: No supplementation; Dietary Supplement: Vitamin D

• Registration Number: NCT00911664
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-05-29
• Study First Submitted QC: 2009-06-01
• Study First Posted: 2009-06-02
• Primary Completion: 2009-10
• Study Completion: 2010-07
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-05
• Last Update Posted: 2014-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	No supplementation	-
2	Vitamin D	-
3	Vitamin D	-

Primary Outcome Measures

Name	Time	Method
Change in CD4 percent associated with vitamin D supplementation in HIV-infected children	6 months

Secondary Outcome Measures

Name	Time	Method
Correlation of the actual 25(OH)D and 1,25(OH)D serum levels with CD4 percent	6 months
Change in absolute CD4 count with vitamin D supplementation	6 months
Change in HIV viral load with vitamin D supplementation	6 months
Other measures of vitamin D metabolism including serum calcium, phosphate, alkaline phosphatase, parathyroid hormone (PTH), and urinary calcium/creatinine ratio	0, 3 and 6 months

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada