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Role of Zinc in Recurrent Acute Lower Respiratory Infections
This study has been completed.
Study NCT00536133   Information provided by Jawaharlal Nehru Medical College
First Received: September 25, 2007   Last Updated: August 3, 2009   History of Changes

September 25, 2007
August 3, 2009
April 2006
May 2008   (final data collection date for primary outcome measure)
change in mean serum zinc level; Number of episodes of ALRI per child ALRI free days per child per year; [ Time Frame: six months ] [ Designated as safety issue: No ]
change in mean serum zinc level; Number of episodes of ALRI per child ALRI free days per child per year; [ Time Frame: six months ]
Complete list of historical versions of study NCT00536133 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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 ]
 
Role of Zinc in Recurrent Acute Lower Respiratory Infections
Role of Zinc in Recurrent Acute Lower Respiratory Infections

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.

 
Phase III
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Acute Respiratory Infections
  • Drug: Zinc
  • Other: placebo
  • Experimental: children with recurrent acute lower respiratory infections receiving zinc supplementation
  • Placebo Comparator: children with recurrent acute lower respiratory infections receiving placebo syrup

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
208
July 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
6 Months to 59 Months
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT00536133
Dr Ubaid Hameed Shah, Jawaharlal Nehru medical college, A.M.U, Aligarh, India
MDPG05/01
Jawaharlal Nehru Medical College
Indian Council of Medical Research
Study Director: Mohd A Malik, MD Professor, Department of pediatrics, Jawaharlal nehru Medical College, A.M.U, Aligarh
Principal Investigator: Ubaid H Shah, MD Jawaharlal Nehru Medical College
Jawaharlal Nehru Medical College
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP