Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months
Condition: Morbidity; Mortality; Diarrhea; Pneumonia
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Zinc and iron folic acid - Intervention; Iron Folic Acid alone - Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The intervention group tablet contained 10 mg of elemental zinc, 12.5 mg of iron and 50 micrograms of folic acid.; The control group tablets were similar in composition, appearance and taste except it contained placebo for zinc.
Intervention MeSH terms: Iron; Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: zinc supplementation; hospitalisations; children; mortality; iron folic acid