- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00133432
Zinc and Pneumonia Protocol
January 28, 2019 updated by: National Institute of Allergy and Infectious Diseases (NIAID)
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.
Study Overview
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 Type
Interventional
Enrollment
600
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dar Es Salaam, Tanzania
- Muhimbili University, College of Health Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 3 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Study Registration Dates
First Submitted
August 19, 2005
First Submitted That Met QC Criteria
August 19, 2005
First Posted (Estimate)
August 23, 2005
Study Record Updates
Last Update Posted (Actual)
January 29, 2019
Last Update Submitted That Met QC Criteria
January 28, 2019
Last Verified
March 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03-179
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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