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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01282788 |
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Date of registration:
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21/01/2011 |
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Primary sponsor: |
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Public title:
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Efficacy of Caterpillar Cereal for Complementary Feeding in the Democratic Republic of Congo
CAT02 |
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Scientific title:
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A Novel Sustainable Complementary Feeding Product for Infants and Young Children in the Democratic Republic of Congo: Caterpillar Cereal |
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Date of first enrolment:
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January 2011 |
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Target sample size:
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220 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01282788 |
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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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Countries of recruitment
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Congo
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Contacts
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Name:
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Carl L Bose, MD |
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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 North Carolina, Chapel Hill |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Infants born in study communities who will reach 6 months of age during the six month
period after initiation of the study
Exclusion Criteria:
- Infants likely to receive free or subsidized complementary foods (or infant formula)
- Families likely to relocate during the study period
- Infants with known congenital anomaly
- Infants of multiple birth
- Infants with neurological deficit apparent at the time of enrollment
Age minimum:
6 Months
Age maximum:
18 Months
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Infectious Diseases Morbidity
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Iron Deficiency Anemia
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Malnutrition
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Neurodevelopmental Impairment
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Stunting of Growth
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Intervention(s)
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Dietary Supplement: Caterpillar Cereal
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Other: Traditional Diet
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Primary Outcome(s)
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Incidence of Stunting of Linear Growth
[Time Frame: 18 months of age]
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Secondary Outcome(s)
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All Cause Mortality
[Time Frame: 6-18 months]
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Compliance
[Time Frame: 6-18 months]
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Developmental Outcome
[Time Frame: 18 months of age]
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Incidence of wasting
[Time Frame: 18 months of age]
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Infectious Disease Morbidity
[Time Frame: 6-18 months]
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Iron Deficiency Anemia
[Time Frame: 18 months]
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Rate of Head Growth
[Time Frame: 18 months of age]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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