Role of Zinc in Recurrent Acute Lower Respiratory Infections

This study has been completed.
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by:
Jawaharlal Nehru Medical College
ClinicalTrials.gov Identifier:
NCT00536133
First received: September 25, 2007
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Role of Zinc in Recurrent Acute Lower Respiratory Infections

Further study details as provided by Jawaharlal Nehru Medical College:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 208
Study Start Date: April 2006
Study Completion Date: July 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Zinc group
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 Comparator: Placebo group
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

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536133

Locations
India
Jawaharlal Nehru Medical College, Aligarh Muslim University
Aligarh, Uttar Pradesh, India, 202002
Sponsors and Collaborators
Jawaharlal Nehru Medical College
Indian Council of Medical Research
Investigators
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Ubaid Hameed Shah, Jawaharlal Nehru medical college, A.M.U, Aligarh, India
ClinicalTrials.gov Identifier: NCT00536133     History of Changes
Other Study ID Numbers: MDPG05/01
Study First Received: September 25, 2007
Last Updated: August 3, 2009
Health Authority: India: Indian Council of Medical Research

Keywords provided by Jawaharlal Nehru Medical College:
zinc
aute lower respiratory infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014