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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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26 September 2016 |
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Main ID: |
NCT02438774 |
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Date of registration:
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06/05/2015 |
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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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Intervention in Minimizing Aflatoxins and Fumonisins Exposure to Children Through Food and Breastfeeding in Tanzania
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Scientific title:
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Effectiveness of Post-harvest Intervention Package in Minimizing Aflatoxins and Fumonisins Exposure to Infants and Young Children Through Maize Based Complementary Foods and Breastfeeding in Rural Tanzania |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02438774 |
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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: Open Label, 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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Tanzania
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Contacts
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Name:
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Martin E Kimanya, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Nelson Mandela African Institution of Science and Technology, Tanzania |
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Name:
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Analice A Kamala, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tanzania Food and Drugs Authority |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Infants aged 0-8 months at the time of recruitment into the study
- Infants currently being breastfed
- Parents anticipated local residence, maize grower and capacity of storing maize for
the period not less than six months after harvest
Exclusion Criteria:
- Abnormalities impairing feeding or physical growth measurements
Age minimum:
N/A
Age maximum:
8 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Growth Retardation
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Intervention(s)
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Behavioral: post-harvest intervention package
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Behavioral: Routine agriculture extension services
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Primary Outcome(s)
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Reduction in aflatoxins and fumonisins contamination in maize and in breast milk after 6 months of intervention
[Time Frame: after 6 months of intervention]
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Secondary Outcome(s)
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The proportion of children exceeding the health based guidance value of aflatoxins and fumonisins Tolerable Daily Intake (TDI) or provisional Maximum Tolerable Daily Intake (PTWI)
[Time Frame: after 6 months of intervention]
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Document post-harvest practices that are effective in reducing contamination of maize with aflatoxins and fumonisins
[Time Frame: after 6 months of intervention]
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Differences in weight - for- age Z-score for intervention and control groups after the intervention
[Time Frame: after 6 months of intervention]
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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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