Water-based Zinc Intervention Trial in Zinc Deficient Children

Early Phase 1

Terminated

• Conditions: Zinc Deficiency; Diarrhea
• Interventions: Device: placebo filter; Other: disinfection tablets; Device: zinc enriching filter (LifeStrawFamily)

• Registration Number: NCT01472211
• Lead Sponsor: Swiss Federal Institute of Technology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-15
• Study First Posted: 2011-11-16
• Primary Completion: 2011-12
• Study Completion: 2012-09
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-17
• Last Update Posted: 2013-06-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 317

Inclusion Criteria

• 2-5 year old children
• subjects residing in the study area for the whole study period

Exclusion Criteria

• subject with severe anemia (Hb < 7 g/dl)
• subjects affected by chronic medical illnesses known to interact with zinc metabolism
• subjects receiving zinc supplementation or other medicines that may affect zinc metabolism

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo filter	placebo filter	children consuming purified water delivered by a household-based water filter
disinfection tablets	disinfection tablets	children will consume water treated with government promoted disinfection tablets (aquatabs)
intervention filter	zinc enriching filter (LifeStrawFamily)	children consuming purified and zinc enriched water delivered by a household-based water filter

Primary Outcome Measures

Name	Time	Method
Zinc status	12 months	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

Name	Time	Method
Gut microbiota characterisation	2 months	At baseline and month 2, stool samples will be collected in 60 children (20 per study arm) for gut flora characterisation.
Iron status	12 months	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 the levels of haemoglobin (Hb) and serum ferritin (SF) for the assessment of iron status.
Growth rate	12 months	At baseline, midpoint and endpoint weight, height and MUAC will be measured in 2-5y children (N=270). Anthropometric measurements will be used to determine growth rate.
Diarrhea prevalence	12 months	Study children will be weekly surveyed for diarrhea occurrence. Mothers/tutors will be requested to report any diarrhea episode occurred in the last 48 hours.

Trial Locations

Locations (1)

Hopital de Zone; 🇧🇯 Natitingou, Atacora, Benin