An Efficacy Trial of a Gravity Fed Household Water Treatment Device as a Delivery System for Zinc

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wageningen University
ClinicalTrials.gov Identifier:
NCT01481181
First received: November 11, 2011
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Diarrhoea
Dietary Supplement: Zinc enriched water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Wageningen University:

Primary Outcome Measures:
  • zinc status [ Time Frame: one year ] [ Designated as safety issue: No ]
    At baseline, endpoint and at a randomly assigned screening between month 1 and 11, a 6 ml whole blood sample will be collected by venipuncture in 2-5y children (N=270). The blood sample will be used to determine concentration of zinc in the serum (SZn). Inflammation indicator C-reactive protein (CRP) will be analysed to adjust SZn values.


Secondary Outcome Measures:
  • rates of diarrhoea and growth in preschool children [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 270
Study Start Date: August 2011
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: zinc enriched water
zinc enriched purified water at 2-6mg/l per day
Dietary Supplement: Zinc enriched water
3mg zinc/L of purified water from a filter installed in the households
No Intervention: purified water only
non zinc enriched, purified drinking water
No Intervention: control group
group of households receiving hygiene practice recommendations and water guard (water purifying solution)

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

Ages Eligible for Study:   2 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481181

Locations
Kenya
Maseno University, School of Public health
Kisumu, Western Kenya, Kenya, +254
Sponsors and Collaborators
Wageningen University
Investigators
Principal Investigator: Michael Zimmerman, MD, PhD ETH Zurich , Wageningen University
Principal Investigator: Diego Moretti, PhD Wageningen University
  More Information

No publications provided

Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT01481181     History of Changes
Other Study ID Numbers: LSF Zinc Kisumu study
Study First Received: November 11, 2011
Last Updated: February 27, 2014
Health Authority: Kenya: Ethical Review Committee

Keywords provided by Wageningen University:
zinc water diarrhoea growth preschool children

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Zinc
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014