DiarrhoeaNCT01481181
An Efficacy Trial of a Gravity Fed Household Water Treatment Device as a Delivery System for Zinc
A study testing Zinc enriched water in people with Diarrhoea, run by Wageningen University at 1 site in Kenya.
Trial summary
In low-income settings in developing countries unsafe water is one of the leading causes of high prevalence of waterborne diseases such as diarrhoea.Zinc is an essential trace element that has a critical role in growth and immunity. Read more about this study
- Who is it for?
- Ages 2 to 45 years
- Conditions the study is for
- Diarrhoea
- What is being tested?
- Zinc enriched water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteKenya
- Study dates
- Aug 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children found to have serum zinc concentration <65μg/dL at pre screening.
- Women that have become pregnant during the study.
Who cannot join
- Subjects with severe anemia (Hb<7g/dl)
- Subjects with severe zinc deficiency (SZn<40 μg/dL)
- Subjects receiving zinc supplementation
- Subject with chronic diseases affecting zinc metabolism, such as kidney diseases or chronic gastrointestinal disease.
- Subjects participating in any other clinical trials in the study site
- Women not residing in the study area until childbirth
Show all 11Show fewer
- Subjects with severe anemia (Hb<7g/dl)
- Subjects with sever zinc deficiency (SZn<40 μg/dL)
- Subjects receiving zinc supplementation
- Subject with chronic diseases affecting zinc metabolism, such as kidney diseases or chronic gastrointestinal disease.
- Subjects currently enrolled in other clinical trials in other trials on the study site
Trial locations and contacts
1 site in 1 country.
Kenya1 site
Maseno University, School of Public health
Kisumu, Western Kenya, +254
About this study
Official title: An Efficacy Trial of a Gravity Fed Household Water Treatment Device as a Delivery System for Zinc in Zinc Deficient Children and Women From Low Income Settings
In low-income settings in developing countries unsafe water is one of the leading causes of high prevalence of waterborne diseases such as diarrhoea.Zinc is an essential trace element that has a critical role in growth and immunity. Supplementation with zinc is considered effective in reducing morbidity from diarrhoeal and other infectious diseases. Verstergaard Frandsen S.A. (Switzerland) has developed a point-of-use water filtration system called LifeStraw®Family (LSF) that removes water's turbidity, reduces the microbiological contamination and enriches water with zinc at a concentration of 3.5 mg/L. The objective of the study is to assess the efficacy of LSF to increase the zinc status (serum zinc concentration) and intake in Kenyan children aged 2-5years with zinc deficiency.The study hypotheses are:
- Use of the LSF device will reduce microbiological contamination of the household supply of drinking and cooking water; B. Use of the LSF device will increase zinc intakes in preschool children; C. Use of the LSF device will increase serum zinc concentration in preschool children; D. Achieving A, B and C will improve growth in preschool children; E. Achieving A, B and C will reduce the frequency and duration of diarrheal disease in preschool children and in members of the participating households.
Read the detailed description
Introduction: In low-income settings in developing countries unsafe water is one of the leading causes of high prevalence of waterborne diseases such as diarrhoea. Point-of-use water treatment systems are currently considered by UNICEF as more effective in delivering safe drinking water than interventions applied at source. Zinc is an essential trace element that has a critical role in growth and immunity. Supplementation with zinc is considered effective in reducing morbidity from diarrhoeal and other infectious diseases. Verstergaard Frandsen S.A. (Switzerland) has developed a point-of-use water filtration system called LifeStraw®Family (LSF) that removes water's turbidity, reduces the microbiological contamination and enriches water with zinc at a concentration of 3.5 mg/L.
Objective: To assess the efficacy of LSF to increase the zinc status (serum zinc concentration) and intake in Kenyan children aged 2-5years with zinc deficiency.
Study Design and Methods: A study population living in an area with low Zn status and sharing the same unimproved water supply will be included in the trial and randomly assigned to one of the treatment groups for 12 months. All households will receive hygiene practice recommendations (HPRs). In addition to HPR, group one will receive the LSF device with the zinc delivery system; group 2 will receive HPRs and a LSF without zinc delivery system, and group 3 will receive HPRs. At baseline, mid-point and end-point, anthropometrics (weight, height, mid-upper arm circumference MUAC), and 7 ml whole blood will be collected from preschool children for determination of SZn, C-reactive protein (CRP), hemoglobin (Hb) and serum ferritin (SF). Children and adult subjects remaining zinc deficient at completion of the trial will receive zinc supplements.
Expected outcome: This study will investigate the efficacy of a water treatment device as a means to provide Zn in communities where high prevalence of surface water use and zinc deficiency coexists. Increasing the microbiological quality of water and the contemporaneous low dose fortification with zinc, could prove useful in the global effort to control zinc deficiency and increase the supply of clean drinking water
- Conditions
- Diarrhoea
- Being tested
- Zinc enriched water
- Keywords
- zinc water diarrhoea growth preschool children
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc enriched waterDietary supplement
3mg zinc/L of purified water from a filter installed in the households
| Study group | Role | What they receive |
|---|---|---|
| zinc enriched water | Experimental | zinc enriched purified water at 2-6mg/l per day Receives: Dietary Supplement: Zinc enriched water |
| purified water only | No intervention | non zinc enriched, purified drinking water |
| control group | No intervention | group of households receiving hygiene practice recommendations and water guard (water purifying solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
rates of diarrhoea and growth in preschool children
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startAug 2011
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrhoeaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Zimmerman, MD, PhD, Principal investigator, ETH Zurich , Wageningen UniversityDiego Moretti, PhD, Principal investigator, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481181
- Sponsor's protocol ID
- LSF Zinc Kisumu study
- Status last verified
- Feb 2014
- First submitted
- 11 Nov 2011
- Last updated
- 28 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Efficacy Trial of a Gravity Fed Household Water Treatment Device as a Delivery System for Zinc in Zinc Deficient Children and Women From Low Income Settings
- ClinicalTrials.gov ID
- NCT01481181
- Acronym / sponsor ID
- LSF Zinc Kisumu study
- Conditions
- Diarrhoea
- Keywords
- zinc water diarrhoea growth preschool children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In low-income settings in developing countries unsafe water is one of the leading causes of high prevalence of waterborne diseases such as diarrhoea.Zinc is an essential trace element that has a critical role in growth and immunity. Supplementation with zinc is considered effective in reducing morbidity from diarrhoeal and other infectious diseases. Verstergaard Frandsen S.A. (Switzerland) has developed a point-of-use water filtration system called LifeStraw®Family (LSF) that removes water's turbidity, reduces the microbiological contamination and enriches water with zinc at a concentration of 3.5 mg/L. The objective of the study is to assess the efficacy of LSF to increase the zinc status (serum zinc concentration) and intake in Kenyan children aged 2-5years with zinc deficiency.The study hypotheses are:
- Use of the LSF device will reduce microbiological contamination of the household supply of drinking and cooking water; B. Use of the LSF device will increase zinc intakes in preschool children; C. Use of the LSF device will increase serum zinc concentration in preschool children; D. Achieving A, B and C will improve growth in preschool children; E. Achieving A, B and C will reduce the frequency and duration of diarrheal disease in preschool children and in members of the participating households.
Detailed description
Introduction: In low-income settings in developing countries unsafe water is one of the leading causes of high prevalence of waterborne diseases such as diarrhoea. Point-of-use water treatment systems are currently considered by UNICEF as more effective in delivering safe drinking water than interventions applied at source. Zinc is an essential trace element that has a critical role in growth and immunity. Supplementation with zinc is considered effective in reducing morbidity from diarrhoeal and other infectious diseases. Verstergaard Frandsen S.A. (Switzerland) has developed a point-of-use water filtration system called LifeStraw®Family (LSF) that removes water's turbidity, reduces the microbiological contamination and enriches water with zinc at a concentration of 3.5 mg/L.
Objective: To assess the efficacy of LSF to increase the zinc status (serum zinc concentration) and intake in Kenyan children aged 2-5years with zinc deficiency.
Study Design and Methods: A study population living in an area with low Zn status and sharing the same unimproved water supply will be included in the trial and randomly assigned to one of the treatment groups for 12 months. All households will receive hygiene practice recommendations (HPRs). In addition to HPR, group one will receive the LSF device with the zinc delivery system; group 2 will receive HPRs and a LSF without zinc delivery system, and group 3 will receive HPRs. At baseline, mid-point and end-point, anthropometrics (weight, height, mid-upper arm circumference MUAC), and 7 ml whole blood will be collected from preschool children for determination of SZn, C-reactive protein (CRP), hemoglobin (Hb) and serum ferritin (SF). Children and adult subjects remaining zinc deficient at completion of the trial will receive zinc supplements.
Expected outcome: This study will investigate the efficacy of a water treatment device as a means to provide Zn in communities where high prevalence of surface water use and zinc deficiency coexists. Increasing the microbiological quality of water and the contemporaneous low dose fortification with zinc, could prove useful in the global effort to control zinc deficiency and increase the supply of clean drinking water
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| zinc enriched water | Experimental | Dietary Supplement: Zinc enriched waterzinc enriched purified water at 2-6mg/l per day |
| purified water only | No intervention | –non zinc enriched, purified drinking water |
| control group | No intervention | –group of households receiving hygiene practice recommendations and water guard (water purifying solution) |
Who may qualify
- Ages
- 2 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children found to have serum zinc concentration <65μg/dL at pre screening.
- Women that have become pregnant during the study.
Key exclusion criteria (11 listed)
- Subjects with severe anemia (Hb<7g/dl)
- Subjects with severe zinc deficiency (SZn<40 μg/dL)
- Subjects receiving zinc supplementation
- Subject with chronic diseases affecting zinc metabolism, such as kidney diseases or chronic gastrointestinal disease.
- Subjects participating in any other clinical trials in the study site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc enriched water3mg zinc/L of purified water from a filter installed in the households | Dietary supplement | zinc enriched water |
Primary outcome
zinc status
Time frame: one year
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.
1 secondary outcome
rates of diarrhoea and growth in preschool children
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Zimmerman, MD, PhD principal investigator
ETH Zurich , Wageningen University
Diego Moretti, PhD principal investigator
Wageningen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc enriched water in people with Diarrhoea, run by Wageningen University at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
zinc status (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2014.