Role of Zinc in Recurrent Acute Lower Respiratory Infections
NCT00536133 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 208
Last updated 2009-08-06
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
Interventions
- DRUG
-
Zinc
5 ml of syrup containing zinc gluconate equivalent to 10 mg of elemental zinc per day for 60 days
- OTHER
-
placebo
5 ml of syrup, identical in taste, color and consistency to the syrup given to zinc group, but containing no zinc
Sponsors & Collaborators
-
Indian Council of Medical Research
collaborator OTHER_GOV -
Jawaharlal Nehru Medical College
lead OTHER
Principal Investigators
-
Mohd A Malik, MD · Professor, Department of pediatrics, Jawaharlal nehru Medical College, A.M.U, Aligarh
-
Ubaid H Shah, MD · Jawaharlal Nehru Medical College
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 59 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-04-30
- Primary Completion
- 2008-05-31
- Completion
- 2008-07-31
Countries
- India
Study Locations
More Related Trials
-
Efficacy of Zinc in the Treatment of Pneumonia
NCT00198666 ·Status: COMPLETED ·Phase: NA
-
Zinc Supplementation for Young Infants With Clinical Severe Infection in Tanzania
NCT06102044 ·Status: RECRUITING ·Phase: PHASE3
-
Daily Zinc Supplement Effect on Prevention of Diarrhea and Acute Respiratory Infections in Children Less Than Five Years
NCT05002101 ·Status: COMPLETED ·Phase: PHASE4
-
Efficacy of Zinc in the Treatment of Bronchiolitis and Prevention of Wheezing Respiratory Illness in Children Less Than Two Years Old
NCT00355043 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Zinc and Vitamin A Supplementation on Diarrhea, Physical Growth and Immune Response in Malnourished Children
NCT00272116 ·Status: COMPLETED ·Phase: NA
-
A Study on Immunological Effect of Vitamin A and Zinc in a Placebo Controlled 4 Cell Trial
NCT00374023 ·Status: COMPLETED ·Phase: NA
-
Efficiency and Safety of Zinc Sulphate to Reduce the Duration of Acute Diarrheal Disease Between 6 and 59 Months of Age
NCT04061538 ·Status: COMPLETED ·Phase: NA
-
Impact of Zinc Supplementation in Low Birth Weight Infants on Severe Morbidity, Mortality and Zinc Status: A Randomized Controlled Trial
NCT00272142 ·Status: COMPLETED ·Phase: NA
-
The Efficacy of Zinc as Adjunct Therapy in the Treatment of Severe Pneumonia in Children
NCT00373100 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Zinc Supplementation on Serum Zinc Level in Nursing Home Elderly
NCT01599572 ·Status: COMPLETED ·Phase: PHASE1
-
Zinc as Adjunct to Treatment of Pneumonia
NCT00513929 ·Status: UNKNOWN ·Phase: NA
-
Efficacy of Use of Zinc in the Treatment of Acute Diarrhea in Infants
NCT01571856 ·Status: COMPLETED ·Phase: PHASE4
-
Zinc Supplementation in Shigella Patients
NCT00321126 ·Status: COMPLETED ·Phase: PHASE3
-
Zinc Supplementation in Children With Sickle Cell Disease in Western Kenya
NCT03293641 ·Status: COMPLETED ·Phase: NA
-
CHIZAP: Community- and Health Facility-Based Intervention With Zinc as Adjuvant Therapy for Childhood Pneumonia
NCT00148733 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Effectiveness of Oral Rehydration Therapy Supplemented With Zinc in the Management of Diarrhea Acute
NCT02601742 ·Status: UNKNOWN ·Phase: PHASE3
-
Effect of Zinc Supplementation on Response to Oral Polio Vaccine in Infants in Pakistan
NCT01229579 ·Status: COMPLETED ·Phase: NA
-
Zinc Supplementation and Severe and Recurrent Diarrhea
NCT01306097 ·Status: COMPLETED ·Phase: NA
-
Immunological and Clinical Responses to Zinc in Children With Diarrhoea
NCT00408356 ·Status: COMPLETED ·Phase: PHASE3
-
Effectiveness of Adding Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting
NCT00278681 ·Status: COMPLETED ·Phase: PHASE1
-
Impact of Home Zinc Treatment for Acute Diarrhea in Children
NCT00530829 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Zinc Sulfate With Probiotics for the Treatment of Acute Diarrhea in Children
NCT01140074 ·Status: UNKNOWN ·Phase: PHASE2
-
A Trial of Zinc and Micronutrients in Tanzanian Children
NCT00421668 ·Status: COMPLETED ·Phase: PHASE3
-
Addition of Zinc to the Current Case Management Package of Diarrhea in a Primary Health Care Setting
NCT00278746 ·Status: COMPLETED ·Phase: NA
-
Zinc Supplementation to Reduce Diarrhea Rates in Adults in Western Kenya.
NCT01166815 ·Status: COMPLETED ·Phase: PHASE2/PHASE3