Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NCH 05004; C6-181-508
Study information
Scientific title
Acronym
Study hypothesis
Daily oral administration of 20 mg of elemental zinc given in addition to standard antimicrobial therapy in hospitalised children aged 2 to 35 months admitted with severe pneumonia reduces the proportion of treatment failures by 30% as compared to children receiving standard antimicrobial therapy alone.
Ethics approval
Approval received from:
1. Ethics Committee of the All India Institute of Medical Sciences on 03/03/2006 (ref: A-01: 03/02/2006
2. Office of the Medical superintendent, Deen Dayal Upadhyay Hospital on 29/08/2006 (ref: F.19(21)06-DDUH/LIB./9382)
3. Institutional ethics committee of Lady Hardinge Medical College & Associated Hospitals on 21/09/2006
4. World Health Organization Research Ethics Review Committee (WHO ERC) on 22/02/2006
Study design
Randomised, placebo controlled, clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Severe and very severe pneumonia
Intervention
Children will be randomised to receive 20 mg of elemental zinc or placebo each day until discharge, and to be completed at home for a total period of 14 days.
Principal investigator:
Shinjini Bhatnagar
Centre For Diarrhoeal Diseases and Nutrition Research
Department of Paediatrics
All India Institute of Medical Sciences
New Delhi-110029
India
Tel.: +91 (0)11 2659 3290
Fax: +91 (0)11 2658 8822
Email: shinjini_bhatnagar@rediffmail.com
Second Sponsor:
Johns Hopkins Bloomberg School of Public Health
615 N Wolfe Street
Baltimore
MD 21205-2179
United States of America
Intervention type
Drug
Phase
Not Specified
Drug names
Elemental zinc
Primary outcome measures
Primary outcome measure will be the proportion of children who become treatment failures on standard antimicrobial therapy.
Secondary outcome measures
1. Time to recovery from severe pneumonia
2. Time to discharge (complete cessation of clinical signs of pneumonia)
Overall trial start date
01/09/2006
Overall trial end date
31/12/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Children 2 months and up to 24 months of age presenting with a cough or difficult breathing of less than seven days duration with:
1. Fast breathing:
1.1. Greater than 50 breaths per minute in children less than 24 months
1.2. Greater than 40 breaths per minute in children 24 to 35 months
2. Crepitations (on auscultation)
3. Presence of chest indrawing or any general danger sign, i.e., lethargy or inability to drink or central cyanosis (defined as severe pneumonia)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
492
Participant exclusion criteria
Children with any of the following features will be excluded:
1. Congenital malformations, e.g., hydrocephalus, structural Central Nervous System (CNS) malformation
2. Known structural defects, which interfere with feeding, for example:
2.1. Cleft palate
2.2. Oesophageal abnormalities
2.3. Intestinal atresia and stenosis
2.4. Malrotation of the gut
2.5. Anorectal malformation
3. Subjects requiring ventilation or ionotropic support
4. Known inborn error of metabolism
5. Chronic disorders of other organs, e.g., neonatal cholestasis, chronic renal failure, pre-existing seizure disorder
6. Infants born of known Human Immunodeficiency Viurs (HIV) mothers
7. Congenital heart disease
8. Known case of bronchial asthma
9. Active measles (fever and rash)
10. Severe malnutrition requiring separate medical attention
11. Children receiving zinc supplements
12. Children documented to have received intravenous antimicrobials for more than 48 hours for current illness
Recruitment start date
01/09/2006
Recruitment end date
31/12/2008
Locations
Countries of recruitment
India
Trial participating centre
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO)
Geneva
CH-1211
Switzerland
Sponsor information
Organisation
The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO) (Switzerland)
Sponsor details
20 Avenue Appia
Geneva
CH-1211
Switzerland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
The Department of Child and Adolescent Health (CAH)/World Health Organisation (WHO) (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
John Hopkins University (JHU) (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23636236
Publication citations
-
Results
Wadhwa N, Chandran A, Aneja S, Lodha R, Kabra SK, Chaturvedi MK, Sodhi J, Fitzwater SP, Chandra J, Rath B, Kainth US, Saini S, Black RE, Santosham M, Bhatnagar S, Efficacy of zinc given as an adjunct in the treatment of severe and very severe pneumonia in hospitalized children 2-24 mo of age: a randomized, double-blind, placebo-controlled trial., Am. J. Clin. Nutr., 2013, 97, 6, 1387-1394, doi: 10.3945/ajcn.112.052951.