Efficacy of Zinc Therapy in Acute Diarrhoea in Young Children
Condition: Acute Watery Diarrhoea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      Diarrhoea continues to be a major cause of mortality and morbidity in young children
      especially in many developing countries. Although the mortality burden of diarrhoea has
      substantially reduced, the morbidity pattern remained almost unchanged. Recent randomized
      controlled supplementation trials in developing countries have consistently shown that zinc
      has the potential to reduce the duration of diarrhoea as well as has preventive effect on
      childhood diarhroea in subsequent months. Currently, international health agencies recommend
      zinc as an important adjunct therapy to treat diarrhoea in developing countries where zinc
      deficiency is highly prevalent and diet is poor in zinc.

      The recommendation is to provide 20 mg elemental zinc daily for 10 days during each episode
      of diarrhoea.

      This study aims at evaluating the relative efficacy of two length of 20 mg zinc therapy (5 vs
      10 days) during acute diarrhoea in a rural community in a community-based individually
      randomized placebo-controlled trial with 20 mg zinc daily and will be conducted in seven
      villages in the ICDDR,B Matlab study area.

      The study will require 2050 acute dirrhoeal episodes to be treated who will be randomly
      allocated to one of the two treatment schedules (20 mg of zinc daily for 5 or 10 days).
      Children who will be allocated to the shorter duration therapy will receive placebo for the
      remaining days to complete 10-day treatment. Female Field Workers (FFWs) will conduct
      diarrhoea surveillance and administer zinc daily at home. Data will be analyzed using
      appropriate statistical procedure.

      Findings of this study will be immensely valuable for deciding recommendation for the
      duration of zinc therapy in the management of acute diarrhoea in young children and will have
      profound programmatic and policy implications for scaling up zinc intervention in the
      community.
    

Detailed description: 
      The proposed study will use a prospective, double-blind, randomized design in which all study
      children with diarrhoea will receive zinc treatment for the first 5 days and then they will
      receive either zinc or a placebo for the second 5 days of the 10 day course according to
      random allocation to evaluate the efficacy of shorter course of zinc treatment (5 days vs 10
      days) during diarrhoea in children less than 5 years of age. Children with diarrhoea will be
      detected through routine daily surveillance by trained Female Field Worker (FFW) in the study
      area and will be enrolled into the study soon after detection and the informed consent of the
      parent is obtained. Zinc will be administered daily by FFWs as 20 mg elemental zinc as single
      dose for 5 or 10 days. Dispersible zinc tablets in blister pack produced by Nutriset® used in
      the national zinc scaling up project will be used for the study. The placebo will also be
      dispersible tablets identical and undistinguishable from zinc tablet in terms of appearance,
      colour, taste and flavour will be obtained from the same manufacturer. The first episode of a
      child will be treated as part of this study although children will be encouraged to take zinc
      if s/he develops diarrhoea during the study period. The dose is about double the Recommended
      Daily Allowance (RDA) for the children which has been chosen considering the poor zinc status
      of the children to be included and replenishment of possible loss of zinc during diarrhoeal
      episode and also to be consistent with the current recommendation in the zinc scaling up
      initiative. Outcome will be assessed daily during routine visit using a precoded
      questionnaire. Although all the children will receive zinc treatment for one of the two
      durations, ones who will be randomly assigned to shorter duration (5 day) will receive zinc
      for the first 5 days and then placebo for the rest of the days to complete 10 days intake.
    

Intervention name(s): ZINC
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ZINC SUPPLEMENTATION; ACUTE DIARRHOEA; UNDER FIVE CHILDREN; RURAL BANGLADESH