Vitamin D Supplementation and CD4 Count in HIV-Infected Children

HIV Clinical Trial

Official title:

Vitamin D Supplementation and CD4 Count in HIV-Infected Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911664
• Other study ID #: 1000012867
• Status: Completed
• Phase: Phase 2
• First received: May 29, 2009
• Last updated: June 5, 2014
• Start date: February 2009
• Est. completion date: July 2010

Study information

• Verified date: June 2014
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV

Intervention

Dietary Supplement:
• Vitamin D
Weekly dose of 5600 IU (800 IU per day)

Drug:
• No supplementation
Control

Dietary Supplement:
• Vitamin D
Weekly dose of 11,200 IU (1600 IU per day)

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in CD4 percent associated with vitamin D supplementation in HIV-infected children		6 months	No
Secondary	Correlation of the actual 25(OH)D and 1,25(OH)D serum levels with CD4 percent		6 months	No
Secondary	Change in absolute CD4 count with vitamin D supplementation		6 months	No
Secondary	Change in HIV viral load with vitamin D supplementation		6 months	No
Secondary	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	Yes