Role of Zinc in Recurrent Acute Lower Respiratory Infections

NCT ID: NCT00536133

Last Updated: 2009-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Zinc group

children with recurrent acute lower respiratory infections receiving zinc supplementation

Group Type: EXPERIMENTAL

Zinc

Intervention Type: DRUG

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

Placebo group

children with recurrent acute lower respiratory infections receiving placebo syrup

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

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

Interventions

Zinc

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

Intervention Type: DRUG

placebo

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indian Council of Medical Research

OTHER_GOV

Sponsor Role: collaborator

Jawaharlal Nehru Medical College

OTHER

Sponsor Role: lead

Responsible Party

Jawaharlal Nehru medical college, A.M.U, Aligarh, India

Principal Investigators

Mohd A Malik, MD

Role: STUDY_DIRECTOR

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

Ubaid H Shah, MD

Role: PRINCIPAL_INVESTIGATOR

Jawaharlal Nehru Medical College

Locations

Jawaharlal Nehru Medical College, Aligarh Muslim University

Aligarh, Uttar Pradesh, India

Countries

India

References

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Reference Type: BACKGROUND

PMID: 12842379 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

PMID: 15572819 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9164774 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11498488 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9651405 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12052800 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22981241 (View on PubMed)

Other Identifiers

MDPG05/01

Identifier Type: -

Identifier Source: org_study_id