Water-based Zinc Intervention Trial in Zinc Deficient Children

Study Overview
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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.

Official Title
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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.

Conditions
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Zinc Deficiency, Diarrhea

Intervention / Treatment
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* Device: zinc enriching filter (LifeStrawFamily)
* Device: placebo filter
* Other: disinfection tablets


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention filter<br>children consuming purified and zinc enriched water delivered by a household-based water filter | Device: zinc enriching filter (LifeStrawFamily)<br>* filter purifies water and enriches it with zinc at 1-4 mg/l.<br>* Other names: LifeStrawFamily by Vestergaards-Frandsen (Switzerland);|
| Placebo Comparator: placebo filter<br>children consuming purified water delivered by a household-based water filter | Device: placebo filter<br>* filter purifies water<br>* Other names: LifeStrawFamily by Vestergaards-Frandsen (Switzerland);|
| Active Comparator: disinfection tablets<br>children will consume water treated with government promoted disinfection tablets (aquatabs) | Other: disinfection tablets<br>* government promoted tablets disinfect water<br>* Other names: Aquatabs water purification tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota characterisation | At baseline and month 2, stool samples will be collected in 60 children (20 per study arm) for gut flora characterisation. | 2 months | 
| Iron 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 the levels of haemoglobin (Hb) and serum ferritin (SF) for the assessment of iron status. | 12 months | 
| Growth rate | 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. | 12 months | 
| Diarrhea prevalence | 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. | 12 months |