Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Drug: zinc supplementation |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Randomized, Double-Blind, Placebo-Controlled Trial of Zinc Supplementation in HIV-1-Infected Children |
- mean difference in log10 HIV-1 viral load at each visit
- mean difference in percentage of CD4+ T-cells at each visit
- number of illness visits
| Estimated Enrollment: | 100 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | September 2004 |
A randomized, double-blind, placebo-controlled equivalence trial of zinc supplementation was conducted at Grey’s 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.
Eligibility| Ages Eligible for Study: | 6 Months to 60 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV-infection
- 6 to 60 months of age
- Not receiving antiretroviral therapy
- Cared for as outpatients at Grey’s Hospital
Exclusion Criteria:
- Receiving antiretroviral therapy
Contacts and Locations| South Africa | |
| Grey's Hospital | |
| Pietermaritzburg, South Africa | |
| Principal Investigator: | William J Moss, MD, MPH | Johns Hopkins Bloomberg School of Public Health |
| Principal Investigator: | Robert E Black, MD, MPH | Johns Hopkins Bloomberg School of Public Health |
| Principal Investigator: | Raziya Bobat, MBChB, MD | Nelson R Mandela School of Medicine, University of KwaZulu-Natal |
| Principal Investigator: | Hoosen Coovadia, MD, MBBS | Doris Duke Medical Research Institute, University of KwaZulu-Natal |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00138047 History of Changes |
| Other Study ID Numbers: | H.22.02.03.25.B1 |
| Study First Received: | August 26, 2005 |
| Last Updated: | December 2, 2005 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
|
zinc HIV children |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Slow Virus Diseases Zinc Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013