Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
Jawaharlal Nehru Medical College Indian Council of Medical Research |
---|---|
Information provided by: | Jawaharlal Nehru Medical College |
ClinicalTrials.gov Identifier: | NCT00536133 |
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.
Condition | Intervention | Phase |
---|---|---|
Acute Respiratory Infections |
Drug: Zinc Other: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Estimated Enrollment: | 240 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | May 2008 |
Arms | Assigned Interventions |
---|---|
Zinc group: Experimental
children with recurrent acute lower respiratory infections receiving zinc supplementation
|
Drug: Zinc
5 ml of syrup containing zinc gluconate equivalent to 10 mg of elemental zinc per day for 60 days
|
Placebo group: Placebo Comparator
children with recurrent acute lower respiratory infections receiving placebo syrup
|
Other: placebo
5 ml of syrup, identical in taste, color and consistency to the syrup given to zinc group, but containing no zinc
|
Ages Eligible for Study: | 6 Months to 59 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ubaid H Shah, M.B.B.S | +919219411228 | me_ubaid@yahoo.co.in |
India, Uttar Pradesh | |
Jawaharlal Nehru Medical College, Aligarh Muslim University | Recruiting |
Aligarh, Uttar Pradesh, India, 202002 |
Principal Investigator: | Mohd A Malik, MD | Professor, Department of pediatrics, Jawaharlal nehru Medical College, A.M.U, Aligarh |
Study ID Numbers: | MDPG05/01 |
Study First Received: | September 25, 2007 |
Last Updated: | September 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00536133 History of Changes |
Health Authority: | India: Indian Council of Medical Research |
zinc aute lower respiratory infections |
Respiratory Tract Diseases Respiratory Tract Infections Zinc |
Trace Elements Micronutrients Recurrence |
Communicable Diseases Respiratory Tract Diseases Respiratory Tract Infections Growth Substances Physiological Effects of Drugs |
Zinc Trace Elements Micronutrients Infection Pharmacologic Actions |