Role of Zinc in Recurrent Acute Lower Respiratory Infections

Sponsor

Jawaharlal Nehru Medical College (Other)

Overall Status

Completed

CT.gov ID

NCT00536133

Collaborator

Indian Council of Medical Research (Other)

208

Enrollment

Location

Arms

Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Infections	Drug: Zinc Other: placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

208 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Role of Zinc in Recurrent Acute Lower Respiratory Infections

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

Jul 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

change in mean serum zinc level; Number of episodes of ALRI per child ALRI free days per child per year; [six months]

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 [six months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 59 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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