Clinical trial NCT01472211: Water-based Zinc Intervention Trial in Zinc Deficient Children
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Zinc Deficiency
Diarrhea
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Université d'Abomey-Calavi
First posted: 2011-11-16
Enrollment: 317
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Zinc status
timeFrame: 12 months
Secondary outcomes:
measure: Gut microbiota characterisation
timeFrame: 2 months
measure: Iron status
timeFrame: 12 months
measure: Growth rate
timeFrame: 12 months
measure: Diarrhea prevalence
timeFrame: 12 months
Other outcomes:
Locations:
city: Natitingou
country: Benin
facility: Hopital de Zone
state: Atacora
Study officials:
affiliation: Swiss Federal Institute of Technology
name: Michael Zimmermann, Prof. Dr.med.
role: STUDY_CHAIR
References:
citation: Galetti V, Mitchikpe CE, Kujinga P, Tossou F, Hounhouigan DJ, Zimmermann MB, Moretti D. Rural Beninese Children Are at Risk of Zinc Deficiency According to Stunting Prevalence and Plasma Zinc Concentration but Not Dietary Zinc Intakes. J Nutr. 2016 Jan;146(1):114-23. doi: 10.3945/jn.115.216606. Epub 2015 Nov 25.