Respiratory Infections, AcutePhase 3NCT00133432
Zinc and Pneumonia Protocol
A Phase 3 study testing Zinc in people with Respiratory Infections, Acute, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in Tanzania.
Trial summary
Undernutrition in children less than five years of age is common throughout sub-Saharan Africa. Nutritional deficiencies may lead to less ability to fight infectious diseases. The purpose of this study is to determine whether zinc supplements plus standard antibiotics reduce the length of hospitalization in children… Read more about this study
- Who is it for?
- Ages 6 to 36 months
- Conditions the study is for
- Respiratory Infections, Acute
- What is being tested?
- Zinc
- How many people
- 600 participants
- Where
- 1 siteTanzania
- Study dates
- Sep 2005to not given
- 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 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age six months to 36 months inclusive.
- A primary clinical diagnosis of acute pneumonia, which consists of a child presenting with cough or difficulty breathing with the following features:
- Tachypnea: Respiratory rate greater than or equal to 50 breaths per minute for children aged 6 months up to 12 months and greater than or equal to 40 breaths per minute for children aged 12 months to 36 months.
- Fever: Temperature greater than or equal to 37.5 degrees Celsius with an axillary thermometer.
- Any one of the following signs: Flaring of alae nasi, visible indrawing of the lower chest wall muscles on inspiration, central cyanosis, inability to feed, lethargy, or crepitations, i.e. short crackling noises heard during the inspiratory phase of respiration.
- Chest x-ray abnormalities consistent with an inflammatory process such as distinctly confined dense abnormality or large pleural effusion (i.e. pneumonia or lower respiratory tract infection), not just any change such as pulmonary edema.
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- Parent/caregiver willing to give informed consent and to allow HIV testing of their child.
- Child able to take study regimen (zinc supplement/placebo).
- Parents/caregivers willing to comply with a follow-up study visit.
- Child is anticipated to survive the episode of pneumonia and has no other serious concomitant medical condition that would affect their ability to survive the acute episode of pneumonia.
Who cannot join
- Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic-kwashiorkor, and kwashiorkor), which requires microniutrient supplementation including zinc or any other sign of severe malnutrition.
- Prior known or current diagnosis of full blown AIDS meeting World Health Organization clinical case definition. Children who are only HIV-positive and have acute pneumonia will not be excluded from the study.
- Subjects with active tuberculosis.
- Subjects with active measles.
- Subjects with known or suspected signs of systemic illness (e.g. sepsis, acute meningitis, hemodynamic instability).
- Subjects with diarrhea defined as passage of 3 or more loose or watery stools in the past 24 hours.
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- Subjects for which the number of days of illness prior to admission is greater than 3 days.
- Known intolerance or allergy to zinc or zinc-containing products.
- Subjects presently receiving zinc supplementation.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Muhimbili University, College of Health Sciences
Dar es Salaam
About this study
Official title: The Effect of Zinc Supplementation on Duration of Hospitalization in Tanzanian Children Presenting With Acute Pneumonia
Undernutrition in children less than five years of age is common throughout sub-Saharan Africa. Nutritional deficiencies may lead to less ability to fight infectious diseases. The purpose of this study is to determine whether zinc supplements plus standard antibiotics reduce the length of hospitalization in children with pneumonia. Six hundred children aged 6-36 months diagnosed with pneumonia and admitted to Muhimbili National Hospital (MNH), Dar es Salaam, Tanzania, will participate in this study. Half of the children will receive daily supplements of zinc, and the other half will receive placebo tablets (dummy pills containing no medication). Each child will be followed for 6 weeks after hospital discharge to check for recovery from the illness. All children in both groups will receive antibiotics and supportive care to manage pneumonia, according to the standards of care at MNH and Amana Municipal Hospital in accordance with the Recommendations of the Ministry of Health, Tanzania.
Read the detailed description
Undernutrition in children less than five years of age is prevalent throughout sub-Saharan Africa and is often associated with multiple micronutrient deficiencies, such as vitamin A and zinc. These deficiencies are probably a reflection of the poverty and poor living conditions that contribute to the lack of proper nutrition. The potential adverse effect of even subclinical deficiency in various micronutrients (including zinc) on optimal physiological function may lead to an exacerbation of infectious diseases in children living in these parts of the world. The primary objective of this randomized, double-blind, placebo-controlled study is to determine whether oral zinc supplementation plus standard antibiotics significantly alters the duration of required hospitalization in children with radiologically confirmed acute pneumonia. Six hundred children aged six months to 36 months diagnosed with radiologically confirmed acute pneumonia and admitted in the general pediatric wards of Muhimbili National Hospital (MNH), Dar es Salaam, Tanzania, will be recruited. Upon enrollment, half of the subjects will receive daily oral supplements of 25 mg of elemental zinc and the control group will receive placebo tablets. Children randomized to receive zinc supplements will be given a daily dose of 25 mL of reconstituted solution from effervescent tablets equivalent to 25 mg of elemental zinc in two divided doses (12.5 mg twice daily) by a study coordinator during the hospital phase of treatment for pneumonia. Children randomized to the control group will receive placebo effervescent tablets identical in taste and appearance to those tablets containing zinc. Compliance to the regimen will be directly observed by the study coordinator, and clinical response will be closely monitored throughout hospital stay. Each child will be followed for six weeks after hospital discharge to assess for recovery from the illness. All children in both groups will receive antibiotics and supportive care to manage pneumonia, as deemed appropriate according to the standards of care as practiced at MNH and Amana Municipal Hospital in accordance with the Recommendations of the Ministry of Health, Tanzania.
- Conditions
- Respiratory Infections, Acute
- Being tested
- Zinc
- Keywords
- Pneumonia, acute respiratory infections, zinc, Tanzania, children, infants, hospitalization
- Medical subject headings
- Respiratory Tract Infections, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZincDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Infections, AcuteStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 600 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133432
- Sponsor's protocol ID
- 03-179
- Status last verified
- Mar 2010
- First submitted
- 19 Aug 2005
- Last updated
- 29 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Zinc Supplementation on Duration of Hospitalization in Tanzanian Children Presenting With Acute Pneumonia
- ClinicalTrials.gov ID
- NCT00133432
- Acronym / sponsor ID
- 03-179
- Conditions
- Respiratory Infections, Acute
- Keywords
- Pneumonia, acute respiratory infections, zinc, Tanzania, children, infants, hospitalization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 600 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Sep 2005
- First posted
- 23 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.
Undernutrition in children less than five years of age is common throughout sub-Saharan Africa. Nutritional deficiencies may lead to less ability to fight infectious diseases. The purpose of this study is to determine whether zinc supplements plus standard antibiotics reduce the length of hospitalization in children with pneumonia. Six hundred children aged 6-36 months diagnosed with pneumonia and admitted to Muhimbili National Hospital (MNH), Dar es Salaam, Tanzania, will participate in this study. Half of the children will receive daily supplements of zinc, and the other half will receive placebo tablets (dummy pills containing no medication). Each child will be followed for 6 weeks after hospital discharge to check for recovery from the illness. All children in both groups will receive antibiotics and supportive care to manage pneumonia, according to the standards of care at MNH and Amana Municipal Hospital in accordance with the Recommendations of the Ministry of Health, Tanzania.
Detailed description
Undernutrition in children less than five years of age is prevalent throughout sub-Saharan Africa and is often associated with multiple micronutrient deficiencies, such as vitamin A and zinc. These deficiencies are probably a reflection of the poverty and poor living conditions that contribute to the lack of proper nutrition. The potential adverse effect of even subclinical deficiency in various micronutrients (including zinc) on optimal physiological function may lead to an exacerbation of infectious diseases in children living in these parts of the world. The primary objective of this randomized, double-blind, placebo-controlled study is to determine whether oral zinc supplementation plus standard antibiotics significantly alters the duration of required hospitalization in children with radiologically confirmed acute pneumonia. Six hundred children aged six months to 36 months diagnosed with radiologically confirmed acute pneumonia and admitted in the general pediatric wards of Muhimbili National Hospital (MNH), Dar es Salaam, Tanzania, will be recruited. Upon enrollment, half of the subjects will receive daily oral supplements of 25 mg of elemental zinc and the control group will receive placebo tablets. Children randomized to receive zinc supplements will be given a daily dose of 25 mL of reconstituted solution from effervescent tablets equivalent to 25 mg of elemental zinc in two divided doses (12.5 mg twice daily) by a study coordinator during the hospital phase of treatment for pneumonia. Children randomized to the control group will receive placebo effervescent tablets identical in taste and appearance to those tablets containing zinc. Compliance to the regimen will be directly observed by the study coordinator, and clinical response will be closely monitored throughout hospital stay. Each child will be followed for six weeks after hospital discharge to assess for recovery from the illness. All children in both groups will receive antibiotics and supportive care to manage pneumonia, as deemed appropriate according to the standards of care as practiced at MNH and Amana Municipal Hospital in accordance with the Recommendations of the Ministry of Health, Tanzania.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Age six months to 36 months inclusive.
- A primary clinical diagnosis of acute pneumonia, which consists of a child presenting with cough or difficulty breathing with the following features:
- Chest x-ray abnormalities consistent with an inflammatory process such as distinctly confined dense abnormality or large pleural effusion (i.e. pneumonia or lower respiratory tract infection), not just any change such as pulmonary edema.
- Parent/caregiver willing to give informed consent and to allow HIV testing of their child.
- Child able to take study regimen (zinc supplement/placebo).
Key exclusion criteria (9 listed)
- Presence of severe malnutrition according to Wellcome Classification (marasmus, marasmic-kwashiorkor, and kwashiorkor), which requires microniutrient supplementation including zinc or any other sign of severe malnutrition.
- Prior known or current diagnosis of full blown AIDS meeting World Health Organization clinical case definition. Children who are only HIV-positive and have acute pneumonia will not be excluded from the study.
- Subjects with active tuberculosis.
- Subjects with active measles.
- Subjects with known or suspected signs of systemic illness (e.g. sepsis, acute meningitis, hemodynamic instability).
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 | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Respiratory Infections, Acute, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 10 inclusion and 9 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: stopped early, as of the sponsor's last update on 29 Jan 2019. 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. 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 was stopped early. Results are not available in the source record.
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.
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 29 Jan 2019.