PneumoniaNCT00198666
Efficacy of Zinc in the Treatment of Pneumonia
A study testing Zinc in people with Pneumonia, run by Johns Hopkins Bloomberg School of Public Health.
Trial summary
This study is designed to evaluate the efficacy of zinc supplementation in the treatment of children under the age of two years who have been hospitalized with severe pneumonia. Read more about this study
- Who is it for?
- Ages Up to 23 months
- Conditions the study is for
- Pneumonia
- What is being tested?
- Zinc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 299 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Aug 2004
- Phase
- Interventional
- 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 Up to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children under two years old hospitalized with Pneumonia
Who cannot join
- healthy children
About this study
Official title: Efficacy of Zinc in the Treatment of Pneumonia in Hospitalized Children Less Than 2 Years of Age
This study is designed to evaluate the efficacy of zinc supplementation in the treatment of children under the age of two years who have been hospitalized with severe pneumonia.
Read the detailed description
This study was a randomized, double-blind, placebo-controlled clinical trial conducted between September 2003 and August 2004 at the Christian Medical College (CMC) Hospital in Vellore, India. CMC Hospital is a large teaching hospital and medical center that is accessed directly by the population of Vellore and adjoining districts and by referrals from local medical practitioners.
- Conditions
- Pneumonia
- Being tested
- Zinc
- Keywords
- Pneumonia, zinc
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZincDrug
Elemental Zinc
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Children with severe pneumonia were randomly assigned to receive supplementation with elemental zinc. Receives: Drug: Zinc |
| Control | No intervention | Children with severe pneumonia were randomly assigned to receive supplementation with placebo tablets. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of severe symptoms
Measured: 2 years
Secondary outcomes (1)
Time to recovery from severe pneumonia
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startSep 2003
- Primary completionAug 2004
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mathuram Santosham, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Mathuram Santosham, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198666
- Sponsor's protocol ID
- H.22.03.01.06.A2
- Status last verified
- Jan 2015
- First submitted
- 12 Sep 2005
- Last updated
- 12 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Coles CL, Bose A, Moses PD, Mathew L, Agarwal I, Mammen T, Santosham M. Infectious etiology modifies the treatment effect of zinc in severe pneumonia. Am J Clin Nutr. 2007 Aug;86(2):397-403. doi: 10.1093/ajcn/86.2.397.
PubMed 17684211
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Zinc in the Treatment of Pneumonia in Hospitalized Children Less Than 2 Years of Age
- ClinicalTrials.gov ID
- NCT00198666
- Acronym / sponsor ID
- H.22.03.01.06.A2
- Conditions
- Pneumonia
- Keywords
- Pneumonia, zinc
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Sep 2003
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 20 Sep 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.
This study is designed to evaluate the efficacy of zinc supplementation in the treatment of children under the age of two years who have been hospitalized with severe pneumonia.
Detailed description
This study was a randomized, double-blind, placebo-controlled clinical trial conducted between September 2003 and August 2004 at the Christian Medical College (CMC) Hospital in Vellore, India. CMC Hospital is a large teaching hospital and medical center that is accessed directly by the population of Vellore and adjoining districts and by referrals from local medical practitioners.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: ZincChildren with severe pneumonia were randomly assigned to receive supplementation with elemental zinc. |
| Control | No intervention | –Children with severe pneumonia were randomly assigned to receive supplementation with placebo tablets. |
Who may qualify
- Ages
- Up to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children under two years old hospitalized with Pneumonia
Key exclusion criteria (1 listed)
- healthy children
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 |
|---|---|---|
| ZincElemental Zinc | Drug | Treatment |
Primary outcome
Duration of severe symptoms
Time frame: 2 years
1 secondary outcome
Time to recovery from severe pneumonia
Time frame: 2 years
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 12 Jan 2015.
- Derived from this study: PubMed 17684211Coles CL, Bose A, Moses PD, Mathew L, Agarwal I, Mammen T, Santosham M. Infectious etiology modifies the treatment effect of zinc in severe pneumonia. Am J Clin Nutr. 2007 Aug;86(2):397-403. doi: 10.1093/ajcn/86.2.397.
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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.
Mathuram Santosham, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
Questions about this trial
What is this clinical trial studying?
A study testing Zinc in people with Pneumonia, run by Johns Hopkins Bloomberg School of Public Health.
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 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 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Duration of severe symptoms (time frame: 2 years). 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 NCT00198666, which also lists 1 linked publication.
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 12 Jan 2015.