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

NCT01481181 | Completed

• 1 other identifier: LSF Zinc Kisumu study
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhoea

Keywords

zinc water diarrhoea growth preschool children

Outcome Measures

Primary Outcomes (1)

• zinc status

  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.

  one year

Secondary Outcomes (1)

• rates of diarrhoea and growth in preschool children

  one year

Study Arms (3)

zinc enriched water

EXPERIMENTAL

zinc enriched purified water at 2-6mg/l per day

Dietary Supplement: Zinc enriched water

purified water only

NO INTERVENTION

non zinc enriched, purified drinking water

control group

NO INTERVENTION

group of households receiving hygiene practice recommendations and water guard (water purifying solution)

Interventions

Zinc enriched water DIETARY_SUPPLEMENT

3mg zinc/L of purified water from a filter installed in the households

zinc enriched water

Eligibility Criteria

• Age: 2 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Wageningen University: lead

Study Sites (1)

Maseno University, School of Public health

Kisumu, Western Kenya, +254, Kenya

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Zimmerman, MD, PhD

  ETH Zurich , Wageningen University

  PRINCIPAL INVESTIGATOR

• Diego Moretti, PhD

  Wageningen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2011
• First Posted: November 29, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

KE (1)