Clinical trial NCT01481181: An Efficacy Trial of a Gravity Fed Household Water Treatment Device as a Delivery System for Zinc
Official title: An Efficacy Trial of a Gravity Fed Household Water Treatment Device as a Delivery System for Zinc in Zinc Deficient Children and Women From Low Income Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhoea
Keywords: zinc water diarrhoea growth preschool children
Lead sponsor: Wageningen University
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 270
Sex: ALL
Minimum age (years): 2
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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

Eligibility criteria: Inclusion Criteria:

* Children found to have serum zinc concentration \<65μg/dL at pre screening.
* Women that have become pregnant during the study.

Exclusion Criteria for children:

* Subjects with severe anemia (Hb\<7g/dl)
* Subjects with severe zinc deficiency (SZn\<40 μg/dL)
* Subjects receiving zinc supplementation
* Subject with chronic diseases affecting zinc metabolism, such as kidney diseases or chronic gastrointestinal disease.
* Subjects participating in any other clinical trials in the study site

Exclusion criteria for women:

* Women not residing in the study area until childbirth
* Subjects with severe anemia (Hb\<7g/dl)
* Subjects with sever zinc deficiency (SZn\<40 μg/dL)
* Subjects receiving zinc supplementation
* Subject with chronic diseases affecting zinc metabolism, such as kidney diseases or chronic gastrointestinal disease.
* Subjects currently enrolled in other clinical trials in other trials on the study site

Primary outcomes:
measure: zinc status
timeFrame: one year
Secondary outcomes:
measure: rates of diarrhoea and growth in preschool children
timeFrame: one year
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: Maseno University, School of Public health
state: Western Kenya
Study officials:
affiliation: ETH Zurich , Wageningen University
name: Michael Zimmerman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wageningen University
name: Diego Moretti, PhD
role: PRINCIPAL_INVESTIGATOR
References: