Zinc and Pneumonia Protocol

NCT00133432 | Terminated Phase 3

• 1 other identifier: 03-179
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Respiratory Infections, Acute

Keywords

Pneumonia, acute respiratory infections, zinc, Tanzania, children, infants, hospitalization

Interventions

Zinc DRUG

Eligibility Criteria

• Age: 6 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Muhimbili University, College of Health Sciences

Dar es Salaam, Tanzania

Location

MeSH Terms

Conditions

Respiratory Tract Infections; Pneumonia

Interventions

Zinc

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Lung Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: August 19, 2005
• First Posted: August 23, 2005
• Study Start: September 1, 2005
• Last Updated: January 29, 2019

Record last verified: 2010-03

Locations

TA (1)