Water-based Zinc Intervention Trial in Zinc Deficient Children

Summary

The overall aim of this trial is to determine whether the use of the household-based water treatment device Life Straw Family (LSF) can be an effective strategy to improve zinc status and health status of vulnerable populations in developing country rural settings with poor access to potable water.

To assess the effectiveness of the LSF strategy (a filter delivering purified and zinc enriched water) a double blind controlled field efficacy trial will take place over a period of 12 months in rural villages in the district of Natitingou, North-West Benin. In order to attain the research objectives the efficacy trial will envisage 3 arms: intervention (zinc enriching filter), placebo (filter) and control group (disinfection tables). During the trial the following outcomes will be monitored: zinc status and growth rate of the participating children, zinc status and pregnancy outcome in a sub-sample of pregnant women (pregnancy sub-study), diarrhea prevalence in all participating subjects, water quality, zinc enrichment of water, and modality and consistency of use of the LSF-device by the study population.

The study hypotheses are: 1) the use of the LSF-device will reduce microbiological contamination of the household water, 2) the use of the LSF-device will increase zinc intakes and serum zinc concentration in preschool children, 3) the use of the LSF-device will increase zinc intakes and serum zinc concentration in pregnant women, 4) the achievement of 1 and 2 will improve growth and lower frequency and length of diarrhea episodes in participating preschool children, 5) the achievement of 1 and 3 will improve pregnancy outcome and lower frequency and length of diarrhea episodes in participating pregnant women, 6) the use of the LSF-device will lower frequency and length of diarrhea episodes in participating households members.

Conditions

• Zinc Deficiency
• Diarrhea

Interventions

DEVICE

zinc enriching filter (LifeStrawFamily)

filter purifies water and enriches it with zinc at 1-4 mg/l.

DEVICE

placebo filter

filter purifies water

OTHER

disinfection tablets

government promoted tablets disinfect water

Sponsors & Collaborators

• Université d'Abomey-Calavi

  collaborator OTHER

• Swiss Federal Institute of Technology

  lead OTHER

Principal Investigators

• Michael Zimmermann, Prof. Dr.med. · Swiss Federal Institute of Technology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

5 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-09-30

Primary Completion

2011-12-31

Completion

2012-09-30

Countries

• Benin

Study Locations