HIV InfectionsPhase 3NCT00446758

Trial of Zinc and HIV Progression in Children

A Phase 3 study testing Zinc in people with HIV Infections, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To examine whether daily oral zinc supplementation to HIV-infected Tanzanian preschool children reduces diarrheal and respiratory morbidity, delays HIV disease progression, and improves growth. Read more about this study

Who is it for?: Ages 6 weeks to 60 months
Conditions the study is for: HIV Infections
What is being tested?: Zinc
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 440 participants
Where: 1 siteTanzania
Study dates: Mar 2008to Mar 2009
Phase: Phase 3
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 weeks to 60 months
All sexes
No healthy volunteers
Child

Who may be able to join

HIV Infected Children under 60 months of age presenting at HIV treatment clinics in Dar es Salaam, Tanzania

Who cannot join

Eligible for ART: CD4 cell counts < 20% or above pediatric clinical stage of HIV disease 3 according to WHO staging system.
Severe acute malnutrition; Major congenital malformations

Trial locations and contacts

1 site in 1 country.

Tanzania1 site

Muhimbili University College of Health Sciences
Dar es Salaam

Other trials in Tanzania

About this study

To examine whether daily oral zinc supplementation to HIV-infected Tanzanian preschool children reduces diarrheal and respiratory morbidity, delays HIV disease progression, and improves growth.

Read the detailed description

The purpose of this study is to examine whether daily oral zinc supplementation to HIV-infected Tanzanian preschool children reduces diarrheal and respiratory morbidity, delays HIV disease progression, and improves growth.

Conditions: HIV Infections
Being tested: Zinc
Keywords: Zinc, HIV, Infants, Children, Morbidity, Child health outcomes, treatment naive, treatment experienced
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ZincDietary supplement
zinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children > 12 months.

Study groups in NCT00446758
Study group	Role	What they receive
Zinc	Experimental	zinc (as zinc sulphate) 12.5 mg orally per day (6.25 mg in children < 12 mo) Receives: Dietary Supplement: Zinc
Placebo	Placebo comparator	Not described Receives: Dietary Supplement: Zinc

What is being measured

The primary outcome is the main question the study is designed to answer.

Morbidity from respiratory and diarrheal infections, HIV disease progression
Measured: every 4 to 6 months until the end of follow-up

Secondary outcomes (1)

growth in height and weight
Measured: every 4 to 6 months until the end of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Mar 2009

First posted13 Mar 2007 (estimated)
Study startMar 2008
Primary completionMar 2009
Study completionMar 2009

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.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 440 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00446758
Sponsor's protocol ID: 14511
Status last verified: Sep 2012
First submitted: 12 Mar 2007
Last updated: 14 Sep 2012
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Trial of Zinc and HIV Progression in Children
ClinicalTrials.gov ID: NCT00446758
Acronym / sponsor ID: 14511
Conditions: HIV Infections
Keywords: Zinc, HIV, Infants, Children, Morbidity, Child health outcomes, treatment naive, treatment experienced
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 440 participants (actual)
Lead sponsor: Harvard School of Public Health (HSPH)University, hospital or other
Collaborators: Thrasher Research Fund, Muhimbili University of Health and Allied Sciences
Study start: Mar 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 13 Mar 2007 (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.

To examine whether daily oral zinc supplementation to HIV-infected Tanzanian preschool children reduces diarrheal and respiratory morbidity, delays HIV disease progression, and improves growth.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Zinc	Experimental	Dietary Supplement: Zinczinc (as zinc sulphate) 12.5 mg orally per day (6.25 mg in children < 12 mo)
Placebo	Placebo comparator	Dietary Supplement: Zinc

Who may qualify

Ages: 6 weeks to 60 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (1 listed)

HIV Infected Children under 60 months of age presenting at HIV treatment clinics in Dar es Salaam, Tanzania

Key exclusion criteria (2 listed)

Eligible for ART: CD4 cell counts < 20% or above pediatric clinical stage of HIV disease 3 according to WHO staging system.
Severe acute malnutrition; Major congenital malformations

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
Zinczinc effervescent tablets: 6.25mg to infants ≤12 months and 12.5 mg to children > 12 months.	Dietary supplement	Placebo, Zinc

Primary outcome

Morbidity from respiratory and diarrheal infections, HIV disease progression
Time frame: every 4 to 6 months until the end of follow-up

1 secondary outcome

growth in height and weight
Time frame: every 4 to 6 months until the end of follow-up

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 14 Sep 2012.

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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.

Eduardo Villamor, MD, DrPH principal investigator

Harvard School of Public Health (HSPH)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Zinc in people with HIV Infections, run by Harvard School of Public Health (HSPH) at 1 site in Tanzania.

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 1 inclusion and 2 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 14 Sep 2012. 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 Tanzania. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Morbidity from respiratory and diarrheal infections, HIV disease progression (time frame: every 4 to 6 months until the end of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00446758.

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 14 Sep 2012.