Assessing Model Parameters for Applying the Retinol Isotope Dilution (RID) Method (SUPERKID)

Wageningen University

Status: Completed

Conditions: Inflammation; Vitamin A Deficiency; Malaria

Treatments: Other: Retinol Isotope Dilution (RID)

Study type: Interventional

Funder types: Other

Identifiers

NCT02996513

WageningenU

Details and patient eligibility

About

For assessing body retinol pools in preschool children, it is recommended that a blood sample is taken 14-21 days after isotope dosing. During this period, dietary intake of vitamin A should be controlled. Shortening of this period as has been validated for adults would reduce the burden for the children as well as improve research efficiency. The aim is to validate a 4-day protocol for assessing body retinol pools in preschool children by modelling data derived by retinol isotope dilution (RID) method. Venous blood samples will be collected of 60 children 4 days after dosing of 0.4 mg 13C-labeled retinyl acetate. A second venous blood sample will be collected at 6, 8, 12 hrs; and 1, 2, 4, 7, 11, 16, 22 and 28 days after dosing in subgroups of 6 children, randomly divided over the 10 additional time points. Body retinol pools will be modelled, and the time point at which a parsimonious model applies (presumably at day 4) will be assessed.

Full description

For assessing body retinol pools in preschool children, it is recommended that a blood sample is taken 14-21 days after isotope dosing. During this period, dietary intake of vitamin A should be controlled. Shortening of this period as has been validated for adults would reduce the burden for the children as well as improve research efficiency. The aim is to validate a 4-day protocol for assessing body retinol pools in preschool children by modelling data derived by retinol isotope dilution (RID) method. A secondary aim is to compare body retinol pools between children with and without inflammation and to assess the effect of asymptomatic malaria on model parameters. Preschool children (n=60), 36-59 months of age, residing in Telemu, Osun State, Nigeria will be recruited for the study. The study design is an observational pre/post study, for which body retinol pools will be measured using the RID method. Venous blood samples will be collected of all children 4 days after dosing of 0.4 mg 13C-labeled retinyl acetate. A second venous blood sample will be collected at 6, 8, 12 hrs; and 1, 2, 4, 7, 11, 16, 22 and 28 days after dosing in subgroups of 6 children, randomly divided over the 10 additional time points. Children presenting with asymptomatic malaria will be treated, and a convenience subsample (n=10) will undergo a second assessment of body retinol pools determined with a venous blood collection on day 4 post-dosing only. Body retinol pools will be modelled, and the time point at which a parsimonious model applies (presumably at day 4) will be assessed. Presence of asymptomatic malaria and markers of inflammation will be assessed in all children at all time points. Body retinol pools and model parameters between subgroups of children with and without asymptomatic malaria and/or inflammation will be compared. Pre/post comparisons of body retinol pool estimates will be done for the follow up subsample.

Enrollment: 60 patients

Sex: All

Ages: 36 to 59 months old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Retinol Isotope dilution (RID)

Experimental group

Description:

A once-off dose of 0.4 mg 13C4-retinyl acetate will be administered to subjects as a capsule

Treatment:

Other: Retinol Isotope Dilution (RID)