Condition category
Infections and Infestations
Date applied
17/04/2007
Date assigned
23/04/2007
Last edited
17/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Olivier Fontaine

ORCID ID

Contact details

The Department of Child and Adolescent Health (CAH)/World Health Organization (WHO)
20 Avenue Appia
Geneva
CH-1211
Switzerland

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

http://www.who.int/child-adolescent-health/

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

  1. 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.

Additional files

Editorial Notes