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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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16 December 2017 |
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Main ID: |
NCT02996513 |
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Date of registration:
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11/11/2016 |
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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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Assessing Model Parameters for Applying the Retinol Isotope Dilution (RID) Method
SUPERKID |
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Scientific title:
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Assessing Model Parameters for Applying the Retinol Isotope Dilution (RID) Method in Preschool Nigerian Children Living in an Area With a High Malaria Burden |
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Date of first enrolment:
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October 2016 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02996513 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Diagnostic. 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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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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Wageningen University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Apparently healthy
- Between 36 and 59 months of age
- Living in the community of Telemu, Osun State, Nigeria, or its neighbouring
communities
Exclusion Criteria:
- Active or recent disease with a potential effect on study outcome
- Hb concentration <70 g/dL
- Mental state that is incompatible with participation in the study
- Recent exposure to 13C-retinol stable isotopes
- Unwillingness to participate by verbal or physical expression
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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Malaria
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Inflammation
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Vitamin A Deficiency
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Intervention(s)
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Other: Retinol Isotope Dilution (RID)
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Primary Outcome(s)
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Vitamin A status
[Time Frame: 28 days]
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Secondary Outcome(s)
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Blood haemoglobin concentration
[Time Frame: 28 days]
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Serum retinol
[Time Frame: 28 days]
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Ferritin concentration
[Time Frame: 28 days]
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Prevalence of inflammation
[Time Frame: 28 days]
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Soluble transferrin receptor concentration
[Time Frame: 28 days]
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Prevalence of malaria (plasmodium falciparum)
[Time Frame: 28 days]
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Retinol binding protein
[Time Frame: 28 days]
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Secondary ID(s)
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WageningenU
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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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