Water-based Zinc Intervention Trial in Zinc Deficient Children

Federal Institute of Technology (ETH) Zurich

Status and phase: Terminated; Early Phase 1

Conditions: Diarrhea; Zinc Deficiency

Treatments: Device: placebo filter; Device: zinc enriching filter (LifeStrawFamily); Other: disinfection tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT01472211

LSF_zinc_study

Details and patient eligibility

About

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.

Enrollment: 317 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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317 participants in 3 patient groups, including a placebo group

intervention filter

Experimental group

Description:

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

Treatment:

Device: zinc enriching filter (LifeStrawFamily)

placebo filter

Placebo Comparator group

Description:

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

Treatment:

Device: placebo filter

disinfection tablets

Active Comparator group

Description:

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

Treatment:

Other: disinfection tablets