Zinc DeficiencyEarly Phase 1NCT01472211
Water-based Zinc Intervention Trial in Zinc Deficient Children
A Early Phase 1 study testing zinc enriching filter (LifeStrawFamily) and disinfection tablets in people with Zinc Deficiency and Diarrhea, run by Swiss Federal Institute of Technology at 1 site in Benin.
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. Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Zinc Deficiency, Diarrhea
- What is being tested?
- zinc enriching filter (LifeStrawFamily) and disinfection tablets
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 317 participants
- Where
- 1 siteBenin
- Study dates
- Sep 2011to Sep 2012
- Phase
- Early Phase 1
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 2-5 year old children
- subjects residing in the study area for the whole study period
Who cannot join
- 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 locations and contacts
1 site in 1 country.
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 Preschool Children and Pregnant Women From Rural Settings With Poor Access to Potable Water in Benin.
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.
- Conditions
- Zinc Deficiency, Diarrhea
- Being tested
- zinc enriching filter (LifeStrawFamily), placebo filter, disinfection tablets
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zinc enriching filter (LifeStrawFamily)Device
Also called LifeStrawFamily by Vestergaards-Frandsen (Switzerland)
filter purifies water and enriches it with zinc at 1-4 mg/l.
placebo filterDevice
Also called LifeStrawFamily by Vestergaards-Frandsen (Switzerland)
filter purifies water
disinfection tabletsOther
Also called Aquatabs water purification tablets
government promoted tablets disinfect water
| Study group | Role | What they receive |
|---|---|---|
| intervention filter | Experimental | children consuming purified and zinc enriched water delivered by a household-based water filter Receives: Device: zinc enriching filter (LifeStrawFamily) |
| placebo filter | Placebo comparator | children consuming purified water delivered by a household-based water filter Receives: Device: placebo filter |
| disinfection tablets | Active comparator | children will consume water treated with government promoted disinfection tablets (aquatabs) Receives: Other: disinfection tablets |
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: 12 months
Secondary outcomes (4)
Gut microbiota characterisation
At baseline and month 2, stool samples will be collected in 60 children (20 per study arm) for gut flora characterisation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionSep 2012
Why it stopped: Zn released from vehicle led to fortification levels higher than planned. New filter will be developed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Zinc DeficiencyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Université d'Abomey-Calavi
- Responsible party
- Principal investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Michael Zimmermann, Prof. Dr.med., Study chair, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472211
- Sponsor's protocol ID
- LSF_zinc_study
- Status last verified
- Jun 2013
- First submitted
- 9 Nov 2011
- Last updated
- 18 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26609168
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2013. 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 Preschool Children and Pregnant Women From Rural Settings With Poor Access to Potable Water in Benin.
- ClinicalTrials.gov ID
- NCT01472211
- Acronym / sponsor ID
- LSF_zinc_study
- Conditions
- Zinc Deficiency, Diarrhea
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Zn released from vehicle led to fortification levels higher than planned. New filter will be developed.
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Université d'Abomey-Calavi
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 16 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intervention filter | Experimental | Device: zinc enriching filter (LifeStrawFamily)children consuming purified and zinc enriched water delivered by a household-based water filter |
| placebo filter | Placebo comparator | Device: placebo filterchildren consuming purified water delivered by a household-based water filter |
| disinfection tablets | Active comparator | Other: disinfection tabletschildren will consume water treated with government promoted disinfection tablets (aquatabs) |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 2-5 year old children
- subjects residing in the study area for the whole study period
Key exclusion criteria (3 listed)
- 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
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 enriching filter (LifeStrawFamily)Also: LifeStrawFamily by Vestergaards-Frandsen (Switzerland)filter purifies water and enriches it with zinc at 1-4 mg/l. | Device | intervention filter |
| placebo filterAlso: LifeStrawFamily by Vestergaards-Frandsen (Switzerland)filter purifies water | Device | placebo filter |
| disinfection tabletsAlso: Aquatabs water purification tabletsgovernment promoted tablets disinfect water | Other | disinfection tablets |
Primary outcome
Zinc status
Time frame: 12 months
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.
4 secondary outcomes
Gut microbiota characterisation
Time frame: 2 months
Iron status
Time frame: 12 months
Growth rate
Time frame: 12 months
Diarrhea prevalence
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Zn released from vehicle led to fortification levels higher than planned. New filter will be developed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2013.
- Derived from this study: PubMed 26609168Galetti 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.
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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 Zimmermann, Prof. Dr.med. study chair
Swiss Federal Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing zinc enriching filter (LifeStrawFamily) and disinfection tablets in people with Zinc Deficiency and Diarrhea, run by Swiss Federal Institute of Technology at 1 site in Benin.
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 3 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: stopped early, as of the sponsor's last update on 18 Jun 2013. 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 Benin. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Zn released from vehicle led to fortification levels higher than planned. New filter will be developed.). Results are not available in the source record.
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: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01472211, which also lists 1 linked publication.
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 18 Jun 2013.