Water-based Zinc Intervention Trial in Zinc Deficient Children

Diarrhea Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01472211
• Other study ID #: LSF_zinc_study
• Status: Terminated
• Phase: Phase 0
• First received: November 9, 2011
• Last updated: June 17, 2013
• Start date: September 2011
• Est. completion date: September 2012

Study information

• Verified date: June 2013
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Benin: Comité National Provisoire d'Ethique pour la Recherche en Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 317
• Est. completion date: September 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Zinc Deficiency

Intervention

Device:
• zinc enriching filter (LifeStrawFamily)
filter purifies water and enriches it with zinc at 1-4 mg/l.
• placebo filter
filter purifies water

Other:
• disinfection tablets
government promoted tablets disinfect water

Locations

Country	Name	City	State
Benin	Hopital de Zone	Natitingou	Atacora

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Université d'Abomey-Calavi

Country where clinical trial is conducted

Benin, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No