NCT01472211

Water-based Zinc Intervention Trial in Zinc Deficient Children

An Efficacy Trial of a Gravity-fed Household Water Treatment Device as a Delivery System for Zinc in Zinc Deficient Preschool Children and Pregnant Women From Rural Settings With Poor Access to Potable Water in Benin.

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 317 (actual)
• Sponsor: Swiss Federal Institute of Technology · Academic / Other
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-12-01
• Completion: 2012-09-01
• First posted: 2011-11-16
• Last updated: 2013-06-18

Locations

1 site across 1 country: Benin