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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01790321 |
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Date of registration:
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07/02/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Water-based Zinc Efficacy Trial in Beninese Shool Children
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Scientific title:
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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. |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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278 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01790321 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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Phase:
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N/A
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Countries of recruitment
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Benin
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Contacts
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Name:
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Michael B Zimmermann, Prof. Dr.med |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Zurich |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- School aged children enrolled in primary school and regularly attending class
Exclusion Criteria:
- 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
Age minimum:
6 Years
Age maximum:
10 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Zinc Deficiency
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Intervention(s)
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Device: LSF-filtering device
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Primary Outcome(s)
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Zinc status
[Time Frame: Baseline, midpont (varying between weeks 5-20), endpoint (week 22)]
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Secondary Outcome(s)
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Anthropometric indices
[Time Frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)]
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Iron status
[Time Frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)]
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Diarrhea incidence
[Time Frame: Weekly, from baseline through to endpoint]
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Malaria prevalence
[Time Frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)]
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ALRI prevalence
[Time Frame: At baseline and endpoint]
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Inflammation status
[Time Frame: Baseline, midpoint (varying between weeks 5-20), endpoint (week 22)]
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Secondary ID(s)
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LSF_Zn_school
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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