An Early Phase 1 interventional study of zinc enriching filter (LifeStrawFamily) and placebo filter in Zinc Deficiency and Diarrhea, sponsored by Swiss Federal Institute of Technology. Terminated at 1 site in Benin. Open to participants aged 2 Years to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-18.
Sponsored by Swiss Federal Institute of Technology · Early Phase 1, Interventional, and Treatment
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.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's enrollment of 317 is above the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Swiss Federal Institute of Technology is the lead sponsor of 154 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
children consuming purified and zinc enriched water delivered by a household-based water filter
Device: zinc enriching filter (LifeStrawFamily)
children consuming purified water delivered by a household-based water filter
Device: placebo filter
children will consume water treated with government promoted disinfection tablets (aquatabs)
Other: disinfection tablets
filter purifies water and enriches it with zinc at 1-4 mg/l.
Also known as: LifeStrawFamily by Vestergaards-Frandsen (Switzerland)
filter purifies water
Also known as: LifeStrawFamily by Vestergaards-Frandsen (Switzerland)
government promoted tablets disinfect water
Also known as: Aquatabs water purification tablets
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.
Time frame: 12 months
Gut microbiota characterisation
At baseline and month 2, stool samples will be collected in 60 children (20 per study arm) for gut flora characterisation.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
The record gives a start of Sep 2011, a primary completion of Dec 2011 and a completion of Sep 2012. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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