Clinical trial NCT00536133: Role of Zinc in Recurrent Acute Lower Respiratory Infections
Official title: Role of Zinc in Recurrent Acute Lower Respiratory Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Respiratory Infections
Keywords: zinc
aute lower respiratory infections
Lead sponsor: Jawaharlal Nehru Medical College
Sponsor class: OTHER
Collaborators: name: Indian Council of Medical Research
First posted: 2007-09-27
Enrollment: 208
Sex: ALL
Minimum age (years): 6
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: change in mean serum zinc level; Number of episodes of ALRI per child ALRI free days per child per year;
timeFrame: six months
Secondary outcomes:
measure: Diarrhoeal episodes per child; morbidity free days per child; mean hospitalization days; change in Weight for age and height for age z scores
timeFrame: six months
Other outcomes:
Locations:
city: Aligarh
country: India
facility: Jawaharlal Nehru Medical College, Aligarh Muslim University
state: Uttar Pradesh
Study officials:
affiliation: Professor, Department of pediatrics, Jawaharlal nehru Medical College, A.M.U, Aligarh
name: Mohd A Malik, MD
role: STUDY_DIRECTOR
affiliation: Jawaharlal Nehru Medical College
name: Ubaid H Shah, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.