Water-based Zinc Intervention Trial in Zinc Deficient Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

317 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Zinc Deficiency Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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intervention filter

children consuming purified and zinc enriched water delivered by a household-based water filter

Group Type EXPERIMENTAL

zinc enriching filter (LifeStrawFamily)

Intervention Type DEVICE

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

placebo filter

children consuming purified water delivered by a household-based water filter

Group Type PLACEBO_COMPARATOR

placebo filter

Intervention Type DEVICE

filter purifies water

disinfection tablets

children will consume water treated with government promoted disinfection tablets (aquatabs)

Group Type ACTIVE_COMPARATOR

disinfection tablets

Intervention Type OTHER

government promoted tablets disinfect water

Interventions

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zinc enriching filter (LifeStrawFamily)

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

Intervention Type DEVICE

placebo filter

filter purifies water

Intervention Type DEVICE

disinfection tablets

government promoted tablets disinfect water

Intervention Type OTHER

Other Intervention Names

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LifeStrawFamily by Vestergaards-Frandsen (Switzerland) LifeStrawFamily by Vestergaards-Frandsen (Switzerland) Aquatabs water purification tablets

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes