Assessment of Zinc Intake From Enriched Water and Other Dietary Sources in Kisumu, Kenya
Condition: Zinc Deficiency
Study type: Interventional

Summary: 
      Introduction: The prevalence of low serum zinc in children under 5 in East Seme, Kisumu is
      73.5% and this is likely due at least in part to low bioavailable zinc from the local
      cereal-based diet. Interventions that will increase zinc intake could prove useful in the
      effort to control zinc deficiency. A potential strategy is to increase zinc intake through
      enriched or fortified water. The Life Straw Family filter (LSF, Verstergaard Frandsen S.A,
      Switzerland) is capable of purifying water and at the same time enriching it with zinc at a
      variable concentration with mean delivery of approximately 1-4mg/L.

      Aims of the study: The primary aim of this study will be to quantify in under 5 year old
      children the contribution of the household LSF device to zinc intake and dietary zinc
      bioavailability in participating households. Secondary objectives are; 1) to assess change in
      serum zinc levels, growth, morbidity in the intervention group compared to control; 2) to
      characterize composition of the intestinal flora of children in the intervention group
      compared to control.

      Study Design and Methods:

      Consenting households from East Seme, Kisumu, Kenya will be randomly allocated to 2 treatment
      arms in an effectiveness study (90 under-five's per treatment arm). Group one will receive
      the LSF device with the zinc delivery system; group 2 will receive a LSF without the zinc
      delivery system.

      Zinc intake will be assessed in a subsample of the under 5 year old children enrolled in the
      effectiveness trial (n=100). This will be estimated by 24 hr recalls administered on 2
      non-consecutive days in the dry and wet season. Selected food samples will be collected for
      direct analysis of zinc and phytic acid content, to supplement data from food composition
      tables (FCT's). The dietary assessment data will be used to estimate the distribution of zinc
      intakes in this age group and the EAR cut-off method will be used to estimate the proportion
      at risk of inadequate intakes.

      Data on water intake from the LSF device will be obtained by personal diaries and tally
      counters. The Zn concentration of the filtered water will be measured weekly. Using these
      data and the data from the dietary assessment, the contribution of the LSF zinc delivery to
      the overall dietary zinc intake will be estimated.

      The effectiveness study will be conducted as a 6-month double blind randomised trial with 3
      assessment time points (baseline, midpoint and endpoint). Three ml (3ml) whole blood will be
      collected from under 5 year old children enrolled in the households for determination of
      serum zinc (SZn), C-reactive protein (CRP), Alpha-1- acid glycoprotein (AGP) and hemoglobin
      (Hb). Stool samples will be collected from a subsample at baseline, midpoint and endpoint in
      the intervention and control group to assess the composition of the gut microflora and gut
      inflammation. Anthropometrics (weight and height) will be measured at baseline, midpoint and
      endpoint of the study. Weekly active surveillance for incidence and severity of malaria,
      diarrhea and other infectious diseases will be done by questionnaire.
    


Intervention name(s): LSF-filtering device
Intervention type(s): Device
Intervention description(s): Device: LSF-filtering device LifeStraw Family is a water purification device that by means of hollow fibres removes solid particles (<0.5 Nephelometric Turbidity units turbidity reduction), bacteria (>Log 6 reduction), viruses (>Log 4 reduction) and cysts (>Log 3 reduction). Zinc enrichment is provided by a chamber housing a zinc releasing glass-plate that is placed annexed to the hollow fibre column. It is estimated that the LSF can provide about 5 mg of zinc/l of filtered water. By consuming daily a portion of 0.6 litres of enriched water, >100% of the age-specific estimated physiologic requirement would be covered, assuming a fractional absorption of 40%.
Other intervention name(s): LifeStraw Family by Vestergaard Frandsen SA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: zinc; diet; water; morbidity; growth