HIV InfectionsPhase 2NCT00138047
Safety and Efficacy of Zinc Supplementation in HIV-1-Infected Children in South Africa
A Phase 2 study testing zinc supplementation in people with HIV Infections, run by Johns Hopkins Bloomberg School of Public Health at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 60 months
- Conditions the study is for
- HIV Infections
- What is being tested?
- zinc supplementation
- How many people
- 100 participants
- Where
- 1 siteSouth Africa
- Study dates
- Mar 2003to Sep 2004
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- HIV-infection
- 6 to 60 months of age
- Not receiving antiretroviral therapy
- Cared for as outpatients at Grey's Hospital
Who cannot join
- Receiving antiretroviral therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Trial of Zinc Supplementation in HIV-1-Infected Children
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.
Read the detailed description
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.
- Conditions
- HIV Infections
- Being tested
- zinc supplementation
- Keywords
- zinc, HIV, children
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc supplementationDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
mean difference in log10 HIV-1 viral load at each visit
Secondary outcomes (2)
mean difference in percentage of CD4+ T-cells at each visit
number of illness visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startMar 2003
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Agency for International Development (USAID), University of KwaZulu, Grey's Hospital
- Investigators
- William J Moss, MD, MPH, Principal investigator, Johns Hopkins Bloomberg School of Public HealthRobert E Black, MD, MPH, Principal investigator, Johns Hopkins Bloomberg School of Public HealthRaziya Bobat, MBChB, MD, Principal investigator, Nelson R Mandela School of Medicine, University of KwaZulu-NatalHoosen Coovadia, MD, MBBS, Principal investigator, Doris Duke Medical Research Institute, University of KwaZulu-Natal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138047
- Sponsor's protocol ID
- H.22.02.03.25.B1
- Status last verified
- Aug 2005
- First submitted
- 26 Aug 2005
- Last updated
- 5 Dec 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Trial of Zinc Supplementation in HIV-1-Infected Children
- ClinicalTrials.gov ID
- NCT00138047
- Acronym / sponsor ID
- H.22.02.03.25.B1
- Conditions
- HIV Infections
- Keywords
- zinc, HIV, children
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- United States Agency for International Development (USAID), University of KwaZulu, Grey's Hospital
- Study start
- Mar 2003
- Study completion
- Sep 2004
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- HIV-infection
- 6 to 60 months of age
- Not receiving antiretroviral therapy
- Cared for as outpatients at Grey's Hospital
Key exclusion criteria (1 listed)
- Receiving antiretroviral therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zinc supplementation | Drug | – |
Primary outcome
mean difference in log10 HIV-1 viral load at each visit
2 secondary outcomes
mean difference in percentage of CD4+ T-cells at each visit
number of illness visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William J Moss, MD, MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
Robert E Black, MD, MPH principal investigator
Johns Hopkins Bloomberg School of Public Health
Raziya Bobat, MBChB, MD principal investigator
Nelson R Mandela School of Medicine, University of KwaZulu-Natal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zinc supplementation in people with HIV Infections, run by Johns Hopkins Bloomberg School of Public Health at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean difference in log10 HIV-1 viral load at each visit. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2005.