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. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT02162238 |
Date of registration:
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16/04/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Assessment of Zinc Intake From Enriched Water and Other Dietary Sources in Kisumu, Kenya
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Scientific title:
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Assessment of Zinc Intake From Enriched Water and Other Dietary Sources in Kisumu, Kenya |
Date of first enrolment:
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February 2014 |
Target sample size:
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186 |
Recruitment status: |
Completed |
URL:
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http://clinicaltrials.gov/show/NCT02162238 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
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Phase:
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N/A
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Countries of recruitment
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Kenya
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Contacts
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Name:
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Michael B Zimmerman, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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ETH Zurich and Wageningen University |
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Name:
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Diego Moretti, PhD |
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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Name:
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Pauline Andango, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Maseno University |
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Name:
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Inge D Brouwer, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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Wageningen University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children (under 5 year olds) in consenting households will participate in the study
Exclusion Criteria:
- Subjects with severe anemia (Hb<7g/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
Age minimum:
2 Years
Age maximum:
5 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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number of participants with adequate zinc intake above the EAR (estimated average requirement)
[Time Frame: 6 months]
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Secondary Outcome(s)
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number of participants with increased serum zinc level from baseline
[Time Frame: at 3 months into intervention and at 6 months]
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morbidity incidence
[Time Frame: every week up to 24 weeks]
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Secondary ID(s)
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Kisumu dietary Zn Study
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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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