An Efficacy Trial of a Gravity Fed Household Water Treatment Device as a Delivery System for Zinc
Condition: Diarrhoea
MeSH terms: Diarrhea
Study type: Interventional

Summary: 
      In low-income settings in developing countries unsafe water is one of the leading causes of
      high prevalence of waterborne diseases such as diarrhoea.Zinc is an essential trace element
      that has a critical role in growth and immunity. Supplementation with zinc is considered
      effective in reducing morbidity from diarrhoeal and other infectious diseases. Verstergaard
      Frandsen S.A. (Switzerland) has developed a point-of-use water filtration system called
      LifeStraw®Family (LSF) that removes water's turbidity, reduces the microbiological
      contamination and enriches water with zinc at a concentration of 3.5 mg/L. The objective of
      the study is to assess the efficacy of LSF to increase the zinc status (serum zinc
      concentration) and intake in Kenyan children aged 2-5years with zinc deficiency.The study
      hypotheses are:

      A. Use of the LSF device will reduce microbiological contamination of the household supply of
      drinking and cooking water; B. Use of the LSF device will increase zinc intakes in preschool
      children; C. Use of the LSF device will increase serum zinc concentration in preschool
      children; D. Achieving A, B and C will improve growth in preschool children; E. Achieving A,
      B and C will reduce the frequency and duration of diarrheal disease in preschool children and
      in members of the participating households.
    

Detailed description: 
      Introduction: In low-income settings in developing countries unsafe water is one of the
      leading causes of high prevalence of waterborne diseases such as diarrhoea. Point-of-use
      water treatment systems are currently considered by UNICEF as more effective in delivering
      safe drinking water than interventions applied at source. Zinc is an essential trace element
      that has a critical role in growth and immunity. Supplementation with zinc is considered
      effective in reducing morbidity from diarrhoeal and other infectious diseases. Verstergaard
      Frandsen S.A. (Switzerland) has developed a point-of-use water filtration system called
      LifeStraw®Family (LSF) that removes water's turbidity, reduces the microbiological
      contamination and enriches water with zinc at a concentration of 3.5 mg/L.

      Objective: To assess the efficacy of LSF to increase the zinc status (serum zinc
      concentration) and intake in Kenyan children aged 2-5years with zinc deficiency.

      Study Design and Methods: A study population living in an area with low Zn status and sharing
      the same unimproved water supply will be included in the trial and randomly assigned to one
      of the treatment groups for 12 months. All households will receive hygiene practice
      recommendations (HPRs). In addition to HPR, group one will receive the LSF device with the
      zinc delivery system; group 2 will receive HPRs and a LSF without zinc delivery system, and
      group 3 will receive HPRs. At baseline, mid-point and end-point, anthropometrics (weight,
      height, mid-upper arm circumference MUAC), and 7 ml whole blood will be collected from
      preschool children for determination of SZn, C-reactive protein (CRP), hemoglobin (Hb) and
      serum ferritin (SF). Children and adult subjects remaining zinc deficient at completion of
      the trial will receive zinc supplements.

      Expected outcome: This study will investigate the efficacy of a water treatment device as a
      means to provide Zn in communities where high prevalence of surface water use and zinc
      deficiency coexists. Increasing the microbiological quality of water and the contemporaneous
      low dose fortification with zinc, could prove useful in the global effort to control zinc
      deficiency and increase the supply of clean drinking water
    

Intervention name(s): Zinc enriched water
Intervention type(s): Dietary Supplement
Intervention description(s): 3mg zinc/L of purified water from a filter installed in the households
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: zinc water diarrhoea growth preschool children