Role of Zinc in Recurrent Acute Lower Respiratory Infections

NCT00536133 | Completed Phase 3 DMC

• 1 other identifier: MDPG05/01
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

Acute respiratory infections (ARIs) are the most frequent illnesses globally. Despite advances in the recognition and management ARIs, these account for over 20% of all child deaths globally.Trace mineral deficiencies have long been implicated in causation and consequences of many diseases. The importance of adequate zinc intake in human health is well documented and zinc deficiency is a large public health problem, especially among children in developing countries.Various studies suggest that zinc-deficient populations are at increased risk of developing diarrhoeal diseases, respiratory tract infections and growth retardation.Among the individual interventions zinc supplementation with universal coverage ranks 5th in preventing under five mortality in India, preceded only in order by breast feeding; complementary feeding; clean delivery; Hib vaccination; and clean water, sanitation and hygiene.Numerous studies have examined the association between child mortality and zinc deficiency. A number of randomized controlled trials evaluating effect of zinc supplementation have found the intervention to be beneficial in reducing ARI and diarrhoeal mortality and morbidity but few studies have found beneficial effect in diarrhea and no or even contrasting effects on morbidity pattern of acute respiratory infections. Whereas role of zinc in diarrhea is now a well established and specific guidelines and recommendations have been given for zinc supplementation in diarrhea, role of zinc in acute respiratory infections is controversial. The contrasting effect of zinc on diarrhoea and acute lower respiratory infection as reported in several studies is a public health concern, because zinc supplementation is carried out in many nutrition rehabilitation units. Further in many of randomized control trials supplement syrups also contained other vitamins, including vitamin A, known to have effect on respiratory morbidity. Most of the trials evaluating effect of zinc on respiratory morbidity and mortality are community based and children with well known causes of recurrent acute lower respiratory infections have not been excluded from the study pool. Hence the current study was planned to bridge this gap of information and attempts to detect the role of zinc using "zinc only preparations" in reducing respiratory morbidity in children aged 6 to 59 months with recurrent acute lower respiratory infections.

Conditions

Acute Respiratory Infections

Keywords

zinc; aute lower respiratory infections

Outcome Measures

Primary Outcomes (1)

• change in mean serum zinc level; Number of episodes of ALRI per child ALRI free days per child per year;

  six months

Secondary Outcomes (1)

• Diarrhoeal episodes per child; morbidity free days per child; mean hospitalization days; change in Weight for age and height for age z scores

  six months

Study Arms (2)

Zinc group

EXPERIMENTAL

children with recurrent acute lower respiratory infections receiving zinc supplementation

Drug: Zinc

Placebo group

PLACEBO COMPARATOR

children with recurrent acute lower respiratory infections receiving placebo syrup

Other: placebo

Interventions

Zinc DRUG

5 ml of syrup containing zinc gluconate equivalent to 10 mg of elemental zinc per day for 60 days

Zinc group

placebo OTHER

5 ml of syrup, identical in taste, color and consistency to the syrup given to zinc group, but containing no zinc

Placebo group

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 to 59 months with documented recurrent acute lower respiratory infection i.e., more than two episodes of ALRI in one year or more than three episodes in any time frame.

You may not qualify if:

• Children with congenital heart diseases
• Children with congenital anomalies which can cause recurrent chest infection
• Children with Tuberculosis
• Children with bronchial asthma or hyperactive airway disease
• Children with WZS \< -2 of HZS \< -2 as per WHO standards
• Children with any diarrhoeal episode in past 3 months
• Children having receive any zinc supplementation in past 3 months
• Children who did not turn up on follow up and could not be contacted were excluded from the study.

Sponsors & Collaborators

• Jawaharlal Nehru Medical College: lead
• Indian Council of Medical Research: collaborator

Study Sites (1)

Jawaharlal Nehru Medical College, Aligarh Muslim University

Aligarh, Uttar Pradesh, 202002, India

Location

Related Publications (8)

• Black RE, Morris SS, Bryce J. Where and why are 10 million children dying every year? Lancet. 2003 Jun 28;361(9376):2226-34. doi: 10.1016/S0140-6736(03)13779-8.

  PMID: 12842379 BACKGROUND

• Caufield L, Black R. Zinc deficiency. In: Ezzati M, Lopez AD, Rodgers A, Murray C, eds. Comparative Quantification of Health Risks: Global and Regional Burden of Disease Attributable to Selected Major Risk Factors. Geneva, Switzerland: World Health Organization; 2004:257-259

  BACKGROUND

• Bhatnagar S, Natchu UC. Zinc in child health and disease. Indian J Pediatr. 2004 Nov;71(11):991-5. doi: 10.1007/BF02828114.

  PMID: 15572819 BACKGROUND

• Ruel MT, Rivera JA, Santizo MC, Lonnerdal B, Brown KH. Impact of zinc supplementation on morbidity from diarrhea and respiratory infections among rural Guatemalan children. Pediatrics. 1997 Jun;99(6):808-13. doi: 10.1542/peds.99.6.808.

  PMID: 9164774 BACKGROUND

• Rahman MM, Vermund SH, Wahed MA, Fuchs GJ, Baqui AH, Alvarez JO. Simultaneous zinc and vitamin A supplementation in Bangladeshi children: randomised double blind controlled trial. BMJ. 2001 Aug 11;323(7308):314-8. doi: 10.1136/bmj.323.7308.314.

  PMID: 11498488 BACKGROUND

• Sazawal S, Black RE, Jalla S, Mazumdar S, Sinha A, Bhan MK. Zinc supplementation reduces the incidence of acute lower respiratory infections in infants and preschool children: a double-blind, controlled trial. Pediatrics. 1998 Jul;102(1 Pt 1):1-5. doi: 10.1542/peds.102.1.1.

  PMID: 9651405 BACKGROUND

• Bhandari N, Bahl R, Taneja S, Strand T, Molbak K, Ulvik RJ, Sommerfelt H, Bhan MK. Effect of routine zinc supplementation on pneumonia in children aged 6 months to 3 years: randomised controlled trial in an urban slum. BMJ. 2002 Jun 8;324(7350):1358. doi: 10.1136/bmj.324.7350.1358.

  PMID: 12052800 BACKGROUND

• Shah UH, Abu-Shaheen AK, Malik MA, Alam S, Riaz M, Al-Tannir MA. The efficacy of zinc supplementation in young children with acute lower respiratory infections: a randomized double-blind controlled trial. Clin Nutr. 2013 Apr;32(2):193-9. doi: 10.1016/j.clnu.2012.08.018. Epub 2012 Aug 31.

  PMID: 22981241 DERIVED

MeSH Terms

Interventions

Zinc

Intervention Hierarchy (Ancestors)

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

Study Officials

• Mohd A Malik, MD

  Professor, Department of pediatrics, Jawaharlal nehru Medical College, A.M.U, Aligarh

  STUDY DIRECTOR

• Ubaid H Shah, MD

  Jawaharlal Nehru Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 25, 2007
• First Posted: September 27, 2007
• Study Start: April 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: July 1, 2008
• Last Updated: August 6, 2009

Record last verified: 2009-08

Locations

IN (1)