Zinc DeficiencyNCT01790321
Water-based Zinc Efficacy Trial in Beninese Shool Children
A study testing LSF-filtering device in people with Zinc Deficiency, run by Prof. Michael B. Zimmermann at 1 site in Benin.
Trial summary
The general objective of this study is to determine the effect of the daily consumption of zinc-fortified water provided by the LSF-filter on zinc status and diarrhea rates in school age children from rural areas characterized by a high risk of zinc deficiency and by elevated stunting prevalence. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Zinc Deficiency
- What is being tested?
- LSF-filtering device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 1 siteBenin
- Study dates
- Feb 2013to Jul 2013
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- School aged children enrolled in primary school and regularly attending class
Who cannot join
- Severe anemia (Hb < 7 g/dl)
- Consumption of a supplement or dietary supplement containing zinc
- Use of drugs that affect the metabolism of zinc
- Suffering from a chronic disease affecting the metabolism of zinc
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Study of Water as Fortification Vehicle for Zinc for Improving Zinc Status in Primary Schools Children in the Municipality of Natitingou, North of Benin.
The general objective of this study is to determine the effect of the daily consumption of zinc-fortified water provided by the LSF-filter on zinc status and diarrhea rates in school age children from rural areas characterized by a high risk of zinc deficiency and by elevated stunting prevalence.
Read the detailed description
A double-blind efficacy study will be carried out over 4 months in school age children enrolled in a primary school equipped with a water pump, in the rural area of the commune of Natitingou, Benin. Participating children will be randomly assigned to one of two groups of intervention or control. On a daily basis, all children will consume a defined quantity of pump-water outside of meals. The water offered to children in the first group of intervention will be previously filtered and zinc-fortified by the LSF-filter; the children in the second group will receive water that has been filtered only. A nutrition survey will provide an indication of dietary zinc intake. The effect of enriched water consumption on children's zinc status will be evaluated by analyzing the concentration of zinc in serum at baseline, midpoint and endpoint of the intervention. Diarrhea rates will be monitored by recording episodes of diarrhea.
- Conditions
- Zinc Deficiency
- Being tested
- LSF-filtering device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LSF-filtering deviceDevice
Also called LifeStraw Family by Vestergaard Frandsen SA
LifeStraw Family is a water purification device that by means of hollow fibres removes solid particles (<0.5 NTU turbidity reduction), bacteria (>Log 6 reduction), viruses (>Log 4 reduction) and cysts (>Log 3 reduction). Zinc fortification is provided by a chamber housing a zinc releasing glass-plate that is placed annexed to the hollow fibre column. It is estimated that the LSF can provide about 5 mg of zinc/l of filtered water. By consuming daily a portion of 0.6 litres of enriched water, >100% of the age-specific estimated physiologic requirement would be covered, assuming a fractional absorption of 40%.
| Study group | Role | What they receive |
|---|---|---|
| Pump water | No intervention | Untreated pump water (pump water recognised as improved water source by WHO) |
| Filtered water | Placebo comparator | Pump water purified by the LSF-filtering device Receives: Device: LSF-filtering device |
| Zinc water | Experimental | Pump water purified and zinc-fortified by the LSF-filtering device Receives: Device: LSF-filtering device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zinc status
Serum zinc concentration
Measured: Baseline, midpont (varying between weeks 5-20), endpoint (week 22)
Secondary outcomes (6)
Inflammation status
Concentration of CRP in serum
Measured: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
Iron status
Haemoglobin level
Measured: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
Diarrhea incidence
Occurrence of diarrhea episodes monitored over 2 days weekly
Measured: Weekly, from baseline through to endpoint
Malaria prevalence
Screening of HRP-II antigen
Measured: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
ALRI prevalence
Auscultation and respiratory frequence (no. of chest movements per minute)
Measured: At baseline and endpoint
Anthropometric indices
Measurement of height, weight and mid-upper arm circumference for the assessment of height-for-age, weight-for-age and BMI-for-age Z-scores.
Measured: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Michael B. Zimmermann
- Sponsor type
- University, hospital or other
- Collaborators
- Université d'Abomey-Calavi
- Responsible party
- Sponsor-investigator, Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
- Investigators
- Michael B Zimmermann, Prof. Dr.med, Study chair, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790321
- Sponsor's protocol ID
- LSF_Zn_school
- Status last verified
- May 2014
- First submitted
- 7 Feb 2013
- Last updated
- 12 May 2014
- 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 26609168Galetti V, Kujinga P, Mitchikpe CE, Zeder C, Tay F, Tossou F, Hounhouigan JD, Zimmermann MB, Moretti D. Efficacy of highly bioavailable zinc from fortified water: a randomized controlled trial in rural Beninese children. Am J Clin Nutr. 2015 Nov;102(5):1238-48. doi: 10.3945/ajcn.115.117028. Epub 2015 Oct 14.
PubMed 26468121
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Water as Fortification Vehicle for Zinc for Improving Zinc Status in Primary Schools Children in the Municipality of Natitingou, North of Benin.
- ClinicalTrials.gov ID
- NCT01790321
- Acronym / sponsor ID
- LSF_Zn_school
- Conditions
- Zinc Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Prof. Michael B. ZimmermannUniversity, hospital or other
- Collaborators
- Université d'Abomey-Calavi
- Study start
- Feb 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 13 Feb 2013 (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 general objective of this study is to determine the effect of the daily consumption of zinc-fortified water provided by the LSF-filter on zinc status and diarrhea rates in school age children from rural areas characterized by a high risk of zinc deficiency and by elevated stunting prevalence.
Detailed description
A double-blind efficacy study will be carried out over 4 months in school age children enrolled in a primary school equipped with a water pump, in the rural area of the commune of Natitingou, Benin. Participating children will be randomly assigned to one of two groups of intervention or control. On a daily basis, all children will consume a defined quantity of pump-water outside of meals. The water offered to children in the first group of intervention will be previously filtered and zinc-fortified by the LSF-filter; the children in the second group will receive water that has been filtered only. A nutrition survey will provide an indication of dietary zinc intake. The effect of enriched water consumption on children's zinc status will be evaluated by analyzing the concentration of zinc in serum at baseline, midpoint and endpoint of the intervention. Diarrhea rates will be monitored by recording episodes of diarrhea.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pump water | No intervention | –Untreated pump water (pump water recognised as improved water source by WHO) |
| Filtered water | Placebo comparator | Device: LSF-filtering devicePump water purified by the LSF-filtering device |
| Zinc water | Experimental | Device: LSF-filtering devicePump water purified and zinc-fortified by the LSF-filtering device |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- School aged children enrolled in primary school and regularly attending class
Key exclusion criteria (4 listed)
- Severe anemia (Hb < 7 g/dl)
- Consumption of a supplement or dietary supplement containing zinc
- Use of drugs that affect the metabolism of zinc
- Suffering from a chronic disease affecting the metabolism of zinc
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 |
|---|---|---|
| LSF-filtering deviceAlso: LifeStraw Family by Vestergaard Frandsen SALifeStraw Family is a water purification device that by means of hollow fibres removes solid particles (<0.5 NTU turbidity reduction), bacteria (>Log 6 reduction), viruses (>Log 4 reduction) and cysts (>Log 3 reduction). Zinc fortification is provided by a chamber housing a zinc releasing glass-plate that is placed annexed to the hollow fibre column. It is estimated that the LSF can provide about 5 mg of zinc/l of filtered water. By consuming daily a portion of 0.6 litres of enriched water, >100% of the age-specific estimated physiologic requirement would be covered, assuming a fractional absorption of 40%. | Device | Filtered water, Zinc water |
Primary outcome
Zinc status
Time frame: Baseline, midpont (varying between weeks 5-20), endpoint (week 22)
Serum zinc concentration
6 secondary outcomes
Inflammation status
Time frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
Iron status
Time frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
Diarrhea incidence
Time frame: Weekly, from baseline through to endpoint
Malaria prevalence
Time frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
ALRI prevalence
Time frame: At baseline and endpoint
Anthropometric indices
Time frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)
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 12 May 2014.
- 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.
- Derived from this study: PubMed 26468121Galetti V, Kujinga P, Mitchikpe CE, Zeder C, Tay F, Tossou F, Hounhouigan JD, Zimmermann MB, Moretti D. Efficacy of highly bioavailable zinc from fortified water: a randomized controlled trial in rural Beninese children. Am J Clin Nutr. 2015 Nov;102(5):1238-48. doi: 10.3945/ajcn.115.117028. Epub 2015 Oct 14.
Related trials for Zinc Deficiency
Active, not recruitingPhase 1
Safety Study of Zinc Finger Nuclease CCR5-modified Hematopoietic Stem/Progenitor Cells in HIV-1 Infected Patients
HIV
Active, not recruitingPhase 1
CD4 CAR+ ZFN-modified T Cells in HIV Therapy
Hiv
Recruiting
Zn Supplementation in HIV Immunological Non Responders
HIV, Zinc Status
Recruiting
Effects of Daily Beef Intake, as a Component of a Heart-Healthy Diet on Cellular Zinc
Zinc Deficiency, Inflammation
RecruitingObservational study
Non-invasive Detection of Iron Deficiency in Obstetrics
Iron Deficiency Anemia of Pregnancy, Iron-deficiency
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 B Zimmermann, Prof. Dr.med study chair
ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LSF-filtering device in people with Zinc Deficiency, run by Prof. Michael B. Zimmermann 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 1 inclusion and 4 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 12 May 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 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.
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: Baseline, midpont (varying between weeks 5-20), endpoint (week 22)). 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 NCT01790321, which also lists 2 linked publications.
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 12 May 2014.