Skip to main content
OpenTrials
Completed

NCT Number: NCT00536133

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

6 month–59 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jawaharlal Nehru Medical College, Aligarh Muslim University

Aligarh, Uttar Pradesh, 202002, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zinc

Drug

5 ml of syrup containing zinc gluconate equivalent to 10 mg of elemental zinc per day for 60 days

Placebo

Other

5 ml of syrup, identical in taste, color and consistency to the syrup given to zinc group, but containing no zinc

Primary outcomes

  1. change in mean serum zinc level; Number of episodes of ALRI per child ALRI free days per child per year;

    Time frame: six months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Jawaharlal Nehru Medical College

Other

Collaborators

  • Indian Council of Medical Research

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 27, 2007
Registry last updated
Aug 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.