Therapeutic Zinc in Childhood Pneumonia

NCT00252304 | Completed Phase 2

• 1 other identifier: INCO-CT-2004-003740-2
• Study Type: interventional
• Target: 641
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to assess whether zinc given as adjuvant therapy to standard antibiotic treatment in children hospitalized for severe pneumonia reduces the duration of the severe illness and risk of treatment failure. A randomized double blind placebo controlled clinical trial will be conducted at the Kanti Hospital.

Conditions

Pneumonia

Keywords

Child, severe pneumonia, Zinc, Nepal, therapeutic

Outcome Measures

Primary Outcomes (2)

• Time to cessation of severe pneumonia

  Within 2 weeks after enrollment

• The period starting from enrolment to the beginning of a 24-hour consecutive period of absence of lower chest indrawing, of hypoxia and of any danger signs.

  Recovery from pneumonia within 2 weeks

Study Arms (2)

Zinc

EXPERIMENTAL

Zinc sulphate 10 or 20 mg per day

Drug: Zinc (zinc sulphate)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Zinc (zinc sulphate) DRUG

Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months

Also known as: Produced by Nutriset, Malaunay, France

Zinc

Placebo DRUG

Placebo

Also known as: Produced by Nutriset, Malaunay, France

Placebo

Eligibility Criteria

• Age: 2 Months - 35 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 2- 35 months with a history of cough (duration \<14days) and difficult breathing of \</= 72hours' duration, with lower chest indrawing.
• Availability of informed consent.

You may not qualify if:

• Children with severe wasting (\<70% NCHS median weight for height)
• Severe anemia (hemoglobin \<7 gm/dl.)
• Presence of heart disease with or without signs of cardiac failure.
• Child with a chronic cough (lasting for ≥14 days)
• Documented tuberculosis with ongoing treatment.
• Associated other severe diseases that require special care or surgical intervention.
• Children with concomitant diarrhea with some/severe dehydration
• Children with a history of recurrent wheezing
• Children enrolled in the study within the last 6 months of this visit

Sponsors & Collaborators

• Centre For International Health: lead
• Tribhuvan University, Nepal: collaborator
• Statens Serum Institut: collaborator
• All India Institute of Medical Sciences: collaborator
• Institut de Recherche pour le Developpement: collaborator
• Society for Applied Studies: collaborator

Study Sites (1)

Kanti Children Hospital

Kathmandu, Nepal

Location

Related Publications (15)

• Nepal Demographic and Health Survey, 2001

  BACKGROUND

• Nepal Ministry of Health, Department of Health Services Annual Report 2000- 2001, Kathmandu

  BACKGROUND

• Shankar AH, Prasad AS. Zinc and immune function: the biological basis of altered resistance to infection. Am J Clin Nutr. 1998 Aug;68(2 Suppl):447S-463S. doi: 10.1093/ajcn/68.2.447S.

  PMID: 9701160 BACKGROUND

• Bahl R, Bhandari N, Hambidge KM, Bhan MK. Plasma zinc as a predictor of diarrheal and respiratory morbidity in children in an urban slum setting. Am J Clin Nutr. 1998 Aug;68(2 Suppl):414S-417S. doi: 10.1093/ajcn/68.2.414S.

  PMID: 9701154 BACKGROUND

• Bhutta ZA, Black RE, Brown KH, Gardner JM, Gore S, Hidayat A, Khatun F, Martorell R, Ninh NX, Penny ME, Rosado JL, Roy SK, Ruel M, Sazawal S, Shankar A. Prevention of diarrhea and pneumonia by zinc supplementation in children in developing countries: pooled analysis of randomized controlled trials. Zinc Investigators' Collaborative Group. J Pediatr. 1999 Dec;135(6):689-97. doi: 10.1016/s0022-3476(99)70086-7.

  PMID: 10586170 BACKGROUND

• Bhandari N, Bahl R, Taneja S, Strand T, Molbak K, Ulvik RJ, Sommerfelt H, Bhan MK. Substantial reduction in severe diarrheal morbidity by daily zinc supplementation in young north Indian children. Pediatrics. 2002 Jun;109(6):e86. doi: 10.1542/peds.109.6.e86.

  PMID: 12042580 BACKGROUND

• Brown KH. Effect of infections on plasma zinc concentration and implications for zinc status assessment in low-income countries. Am J Clin Nutr. 1998 Aug;68(2 Suppl):425S-429S. doi: 10.1093/ajcn/68.2.425S.

  PMID: 9701156 BACKGROUND

• Beisel WR. Zinc metabolism in infection. In: Brewer GJ, Prasad AS, eds. Zinc metabolism: current aspects in health and disease. New York: Alan R Liss, 1977: 973-977

  BACKGROUND

• Cousins RJ, Leinart AS. Tissue-specific regulation of zinc metabolism and metallothionein genes by interleukin 1. FASEB J. 1988 Oct;2(13):2884-90. doi: 10.1096/fasebj.2.13.2458983.

  PMID: 2458983 BACKGROUND

• Strand TA, Hollingshead SK, Julshamn K, Briles DE, Blomberg B, Sommerfelt H. Effects of zinc deficiency and pneumococcal surface protein a immunization on zinc status and the risk of severe infection in mice. Infect Immun. 2003 Apr;71(4):2009-13. doi: 10.1128/IAI.71.4.2009-2013.2003.

  PMID: 12654820 BACKGROUND

• Bhutta ZA, Bird SM, Black RE, Brown KH, Gardner JM, Hidayat A, Khatun F, Martorell R, Ninh NX, Penny ME, Rosado JL, Roy SK, Ruel M, Sazawal S, Shankar A. Therapeutic effects of oral zinc in acute and persistent diarrhea in children in developing countries: pooled analysis of randomized controlled trials. Am J Clin Nutr. 2000 Dec;72(6):1516-22. doi: 10.1093/ajcn/72.6.1516.

  PMID: 11101480 BACKGROUND

• Strand TA, Chandyo RK, Bahl R, Sharma PR, Adhikari RK, Bhandari N, Ulvik RJ, Molbak K, Bhan MK, Sommerfelt H. Effectiveness and efficacy of zinc for the treatment of acute diarrhea in young children. Pediatrics. 2002 May;109(5):898-903. doi: 10.1542/peds.109.5.898.

  PMID: 11986453 BACKGROUND

• Brooks WA, Yunus M, Santosham M, Wahed MA, Nahar K, Yeasmin S, Black RE. Zinc for severe pneumonia in very young children: double-blind placebo-controlled trial. Lancet. 2004 May 22;363(9422):1683-8. doi: 10.1016/S0140-6736(04)16252-1.

  PMID: 15158629 BACKGROUND

• Haugen J, Basnet S, Hardang IM, Sharma A, Mathisen M, Shrestha P, Valentiner-Branth P, Strand TA. Vitamin D status is associated with treatment failure and duration of illness in Nepalese children with severe pneumonia. Pediatr Res. 2017 Dec;82(6):986-993. doi: 10.1038/pr.2017.71. Epub 2017 Aug 16.

  PMID: 28678771 DERIVED

• Basnet S, Shrestha PS, Sharma A, Mathisen M, Prasai R, Bhandari N, Adhikari RK, Sommerfelt H, Valentiner-Branth P, Strand TA; Zinc Severe Pneumonia Study Group. A randomized controlled trial of zinc as adjuvant therapy for severe pneumonia in young children. Pediatrics. 2012 Apr;129(4):701-8. doi: 10.1542/peds.2010-3091. Epub 2012 Mar 5.

  PMID: 22392179 DERIVED

MeSH Terms

Conditions

Pneumonia

Interventions

Zinc; Zinc Sulfate

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Zinc Compounds

Study Officials

• Sudha Basnet, MD

  Department of Child Health, Institute of Medicine, Tribhuwan University, Katmandu, Nepal

  PRINCIPAL INVESTIGATOR

• Tor A Strand, MD, PhD

  Centre For International Health

  STUDY DIRECTOR

• Halvor Sommerfelt, MD, PhD

  Centre For International Health

  STUDY CHAIR

• Nita Bhandari, MBBS, PhD

  Centre For International Health

  STUDY CHAIR

• Prakash S Shrestha, MD

  Child Health Research Project, Department of Child Health, Institute of Medicine, Maharajganj:

  STUDY DIRECTOR

• Ramesh K Adhikari, MD

  Child Health Research Project, Department of Child Health, Institute of Medicine, Maharajganj:

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 11, 2005
• Study Start: January 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: October 6, 2009

Record last verified: 2009-10

Locations

NE (1)