Pneumonia Clinical Trial
Official title:
Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months
Children, aged 1 months to 23 months, in the intervention households received zinc, iron and folic acid and those in the control households were administered iron and folic acid (IFA) alone for a period of one year. The primary outcomes were hospitalizations and deaths during this period.
Objective: Studies in developing countries show substantial reduction in diarrhoea and
respiratory morbidity in young children receiving zinc supplementation. The impact of daily
zinc supplementation coadministered with iron folic acid in young children on all cause
hospitalisation and mortality in comparison with iron folic acid alone, was evaluated to
help shape public policy.
Design: Randomised double blind trial
Setting: Low to middle socio-economic urban neighbourhoods of north and north-west Delhi in
India
Participants: 94359 subjects aged 1 month to 23 months
Interventions: The subjects were administered dispersible tablets containing one recommended
daily allowance of zinc and iron folic acid or iron folic acid alone, daily for 12 months
after enrolment.
Main outcome measures: Hospitalisations were captured through passive surveillance of eight
hospitals by trained study physicians. Deaths were ascertained through bimonthly visits to
households.
Results: A third of the total children had low zinc levels (<60 mg/dL) and one fourth had
iron deficiency (haematocrit <33%) at baseline. The proportion zinc deficient was
significantly lower post 12 months supplementation, in the zinc and iron folic acid group
(difference in proportions -10%; 95% confidence interval -15.6% to -4.4%, p 0.0005). Only
7.7% in the zinc and iron folic acid and 7.3% in the iron folic acid group had low
haematocrit. Zinc and iron folic acid supplementation had no impact on hospitalisations,
overall and cause-specific. The overall death rates were similar in the two groups.
Conclusions: The lack of mortality impact may be real or the findings could have resulted
from the use of lower daily zinc dosing than in morbidity prevention trials or an
interaction between zinc and iron whereby adding iron, may have adversely affected potential
effects of zinc on immune function and morbidity. Future research should address iron and
zinc interaction effects on important functional outcomes.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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