An interventional study of Retinol Isotope Dilution (RID) in Vitamin A Deficiency, Malaria and Inflammation, sponsored by Wageningen University. Completed at 1 site in Nigeria. Open to participants aged 36 Months to 59 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-08-25.
Sponsored by Wageningen University · Not applicable, Interventional, and Diagnostic
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.
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.
67 studies on the registry are indexed under Vitamin A Deficiency; 7 are open to participants now.
This study's enrollment of 60 is below the median of 200 across 49 interventional studies indexed under Vitamin A Deficiency.
Browse Vitamin A Deficiency studies →Wageningen University is the lead sponsor of 153 studies on the registry; 15 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A once-off dose of 0.4 mg 13C4-retinyl acetate will be administered to subjects as a capsule
Other: Retinol Isotope Dilution (RID)
13C-retinyl acetate will be administered to subjects in order to assess their body retinol pools
Vitamin A status
Body retinol pool
Time frame: 28 days
Prevalence of malaria (plasmodium falciparum)
Percentage of children with malaria (Plasmodium falciparum) as determined by a rapid test (CareStart Malaria HRP2) and confirmed by PCR.
Time frame: 28 days
Prevalence of inflammation
Percentage of children with C-reactive protein (CRP) \>5 mg/L and/or alpha-glycoprotein (AGP) \>1 g/L
Time frame: 28 days
Serum retinol
Serum concentration of retinol (HPLC)
Time frame: 28 days
Blood haemoglobin concentration
Haemoglobin concentration (Quikread)
Time frame: 28 days
Ferritin concentration
Serum concentration of ferritin (ELISA)
Time frame: 28 days
Soluble transferrin receptor concentration
Serum concentration of soluble transferrin receptor concentration (ELISA)
Time frame: 28 days
Retinol binding protein
Serum concentration of retinol binding protein (ELISA)
Time frame: 28 days
Body weight
Body weight will be measured to the nearest 0.1 kg with a weighing scale
Time frame: Baseline
Dietary intake of energy, protein, fat, carbohydrates, vitamins and minerals
Group mean intake of macronutrients and micronutrients, assessed by 24h recall
Time frame: Baseline
Body length
Body length will be measured to the nearest 1 cm with a stadiometer
Time frame: Baseline
Plan to share: No
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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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