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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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12 December 2020 |
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Main ID: |
NCT02484495 |
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Date of registration:
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16/06/2015 |
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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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Extended Pilot Project Community Based Production of Complementary Food in Ethiopia
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Scientific title:
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Evaluate the Impact of Package of Interventions on Growth and Micronutrient Status of Infant and Young Children |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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1800 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02484495 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Ethiopia
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Contacts
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Name:
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Inge D Brouwer, 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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Wageningen University |
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Name:
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Saskia JM Osendarp, 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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Micronutrient Initiative |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children between 6-23 m of age who receive Complementary Food (CF) through grain bank
or commercial central production
- Living in one of the selected clusters(for intervention and nonintervention clusters)
- Those who receive MNP (15 sachets/month/child)
- Receive enhanced IYCF counselling
- Receive food based Complementary Food Recommendation (CFR)
- Free of chronic conditions that may impact their health
Exclusion criteria:
- Children between 6-23 m of age who do not get CF either through grain bank program or
central production
- Those who do not get MNP
- Those who do not receive food based CFR
- Children with a chronic disease and/or chronic use of medications
Age minimum:
6 Months
Age maximum:
29 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Growth Acceleration
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Infant Morbidity
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Intervention(s)
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Other: Program evaluation (impact assessment)
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Primary Outcome(s)
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% of children 17-29 months of age with HAZ < -2 SD
[Time Frame: Up to 18 months]
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Secondary Outcome(s)
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Morbidity
[Time Frame: Up to 18 months]
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Mean weight
[Time Frame: Up to 18 months]
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% of children 6-23 months of age who were fed an minimum acceptable diet
[Time Frame: Up to 18 months]
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Mean height
[Time Frame: Up to 18 months]
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Anemia status
[Time Frame: Up to 18 months]
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Z score:
[Time Frame: Up to 18 months]
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Secondary ID(s)
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EPHI_FSNRD_CF_MNP002
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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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