Role of Zinc in Recurrent Acute Lower Respiratory Infections

Acute Respiratory Infections Clinical Trial

Official title:

Role of Zinc in Recurrent Acute Lower Respiratory Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00536133
• Other study ID #: MDPG05/01
• Status: Completed
• Phase: Phase 3
• First received: September 25, 2007
• Last updated: August 3, 2009
• Start date: April 2006
• Est. completion date: July 2008

Study information

• Verified date: August 2009
• Source: Jawaharlal Nehru Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: July 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 59 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Respiratory Infections
• Communicable Diseases
• Infection
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
India	Jawaharlal Nehru Medical College, Aligarh Muslim University	Aligarh	Uttar Pradesh

Sponsors (2)

Lead Sponsor	Collaborator
Jawaharlal Nehru Medical College	Indian Council of Medical Research

Country where clinical trial is conducted

India, 

References & Publications (7)

Bhandari N, Bahl R, Taneja S, Strand T, Mølbak K, Ulvik RJ, Sommerfelt H, Bhan MK. Effect of routine zinc supplementation on pneumonia in children aged 6 months to 3 years: randomised controlled trial in an urban slum. BMJ. 2002 Jun 8;324(7350):1358. — View Citation

Bhatnagar S, Natchu UC. Zinc in child health and disease. Indian J Pediatr. 2004 Nov;71(11):991-5. Review. — View Citation

Black RE, Morris SS, Bryce J. Where and why are 10 million children dying every year? Lancet. 2003 Jun 28;361(9376):2226-34. Review. — View Citation

Caufield L, Black R. Zinc deficiency. In: Ezzati M, Lopez AD, Rodgers A, Murray C, eds. Comparative Quantification of Health Risks: Global and Regional Burden of Disease Attributable to Selected Major Risk Factors. Geneva, Switzerland: World Health Organization; 2004:257-259

Rahman MM, Vermund SH, Wahed MA, Fuchs GJ, Baqui AH, Alvarez JO. Simultaneous zinc and vitamin A supplementation in Bangladeshi children: randomised double blind controlled trial. BMJ. 2001 Aug 11;323(7308):314-8. — View Citation

Ruel MT, Rivera JA, Santizo MC, Lönnerdal B, Brown KH. Impact of zinc supplementation on morbidity from diarrhea and respiratory infections among rural Guatemalan children. Pediatrics. 1997 Jun;99(6):808-13. — View Citation

Sazawal S, Black RE, Jalla S, Mazumdar S, Sinha A, Bhan MK. Zinc supplementation reduces the incidence of acute lower respiratory infections in infants and preschool children: a double-blind, controlled trial. Pediatrics. 1998 Jul;102(1 Pt 1):1-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in mean serum zinc level; Number of episodes of ALRI per child ALRI free days per child per year;		six months	No
Secondary	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	No