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Role of Zinc in Recurrent Acute Lower Respiratory Infections

Primary Purpose

Acute Respiratory Infections

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Zinc
placebo
Sponsored by
Jawaharlal Nehru Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Respiratory Infections focused on measuring zinc, aute lower respiratory infections

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Jawaharlal Nehru Medical College, Aligarh Muslim University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zinc group

Placebo group

Arm Description

children with recurrent acute lower respiratory infections receiving zinc supplementation

children with recurrent acute lower respiratory infections receiving placebo syrup

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2007
Last Updated
August 3, 2009
Sponsor
Jawaharlal Nehru Medical College
Collaborators
Indian Council of Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT00536133
Brief Title
Role of Zinc in Recurrent Acute Lower Respiratory Infections
Official Title
Role of Zinc in Recurrent Acute Lower Respiratory Infections
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Jawaharlal Nehru Medical College
Collaborators
Indian Council of Medical Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Infections
Keywords
zinc, aute lower respiratory infections

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zinc group
Arm Type
Experimental
Arm Description
children with recurrent acute lower respiratory infections receiving zinc supplementation
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
children with recurrent acute lower respiratory infections receiving placebo syrup
Intervention Type
Drug
Intervention Name(s)
Zinc
Intervention Description
5 ml of syrup containing zinc gluconate equivalent to 10 mg of elemental zinc per day for 60 days
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
5 ml of syrup, identical in taste, color and consistency to the syrup given to zinc group, but containing no zinc
Primary Outcome Measure Information:
Title
change in mean serum zinc level; Number of episodes of ALRI per child ALRI free days per child per year;
Time Frame
six months
Secondary Outcome Measure Information:
Title
Diarrhoeal episodes per child; morbidity free days per child; mean hospitalization days; change in Weight for age and height for age z scores
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohd A Malik, MD
Organizational Affiliation
Professor, Department of pediatrics, Jawaharlal nehru Medical College, A.M.U, Aligarh
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ubaid H Shah, MD
Organizational Affiliation
Jawaharlal Nehru Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jawaharlal Nehru Medical College, Aligarh Muslim University
City
Aligarh
State/Province
Uttar Pradesh
ZIP/Postal Code
202002
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
12842379
Citation
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.
Results Reference
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Citation
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
Results Reference
background
PubMed Identifier
15572819
Citation
Bhatnagar S, Natchu UC. Zinc in child health and disease. Indian J Pediatr. 2004 Nov;71(11):991-5. doi: 10.1007/BF02828114.
Results Reference
background
PubMed Identifier
9164774
Citation
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.
Results Reference
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PubMed Identifier
11498488
Citation
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.
Results Reference
background
PubMed Identifier
9651405
Citation
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.
Results Reference
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PubMed Identifier
12052800
Citation
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.
Results Reference
background
PubMed Identifier
22981241
Citation
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.
Results Reference
derived

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Role of Zinc in Recurrent Acute Lower Respiratory Infections

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