A Phase 3 interventional study of Zinc and placebo in Acute Respiratory Infections, sponsored by Jawaharlal Nehru Medical College. Completed at 1 site in India. Open to participants aged 6 Months to 59 Months. Per ClinicalTrials.gov, last updated 2009-08-06.
Sponsored by Jawaharlal Nehru Medical College · Phase 3, Interventional, and Prevention
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.
Jawaharlal Nehru Medical College is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
children with recurrent acute lower respiratory infections receiving zinc supplementation
Drug: Zinc
children with recurrent acute lower respiratory infections receiving placebo syrup
Other: placebo
5 ml of syrup containing zinc gluconate equivalent to 10 mg of elemental zinc per day for 60 days
5 ml of syrup, identical in taste, color and consistency to the syrup given to zinc group, but containing no zinc
change in mean serum zinc level; Number of episodes of ALRI per child ALRI free days per child per year;
Time frame: six months
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
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zinc
Jawaharlal Nehru Medical College