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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: |
NCT02627222 |
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Date of registration:
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08/12/2015 |
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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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The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children
CASSAVITA II |
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Scientific title:
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The Efficacy of Pro-vitamin A Biofortified Cassava on Vitamin A Status in Nigerian Preschool Children |
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Date of first enrolment:
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December 2015 |
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Target sample size:
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176 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02627222 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Nigeria
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Contacts
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Name:
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Alida Melse-Boonstra, 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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Division of Human Nutrition, Wageningen University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Aged 36 - 59 months (verified by birth certificates, vaccination cards or other formal
documentation)
- Apparently healthy
- Parental informed consent
Exclusion Criteria:
- Frequently absent (>20% of feeding days) during run-in
- Children not assenting during blood collections
- Signs or history of infectious or systemic diseases (e.g. tuberculosis, sickle cell
anaemia)
- Mental status that is incompatible with the proper conduct of the study
- Current participation in other research
- Food allergy related to the intervention foods
Age minimum:
36 Months
Age maximum:
59 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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Vitamin A Deficiency
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Intervention(s)
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Other: White cassava
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Other: Pro-vitamin A biofortified cassava
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Primary Outcome(s)
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Body retinol pool (omitted)
[Time Frame: 13 weeks]
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(Modified primary outcome): Serum retinol
[Time Frame: 13 weeks]
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Secondary Outcome(s)
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Anaemia
[Time Frame: 13 weeks]
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Gut integrity
[Time Frame: 11 weeks]
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Secondary ID(s)
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CASSAVITA II
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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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