Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138047
Status:
COMPLETED
Last Update Posted:
2005-12-05
First Post:
2005-08-26
Brief Title:
Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Trial of Zinc Supplementation in HIV-1-Infected Children
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of the study is to rule out a harmful effect of zinc supplementation in HIV-1-infected children The null hypothesis is that zinc supplementation will increase plasma HIV RNA levels
Detailed Description:
A randomized double-blind placebo-controlled equivalence trial of zinc supplementation was conducted at Greys Hospital in Pietermaritzburg South Africa Ninety-six HIV-1-infected children were randomly assigned to receive 10 mg of elemental zinc as sulfate or placebo daily for 6 months Baseline measurements of plasma HIV-1 viral load and the percentage of CD4 T-lymphocytes were established at two study visits prior to randomization and measurements were repeated 3 6 and 9 months after starting supplementation Plasma HIV-1 viral load and the percentage of CD4 T-lymphocytes were compared before and after supplementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None