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

Inflammation Clinical Trial

— SUPERKID  

Official title:

Assessing Model Parameters for Applying the Retinol Isotope Dilution (RID) Method in Preschool Nigerian Children Living in an Area With a High Malaria Burden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02996513
• Other study ID #: WageningenU
• Status: Completed
• Phase: N/A
• First received: November 11, 2016
• Last updated: August 24, 2017
• Start date: October 2016
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Wageningen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 36 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Malaria
• Night Blindness
• Vitamin A Deficiency

Intervention

Other:
• Retinol Isotope Dilution (RID)
13C-retinyl acetate will be administered to subjects in order to assess their body retinol pools

Locations

Country	Name	City	State
Nigeria	University of Ibadan	Ibadan	Oyo State

Sponsors (6)

Lead Sponsor	Collaborator
Wageningen University	HarvestPlus, Newcastle University, Penn State University, University of California, Davis, University of Ibadan

Country where clinical trial is conducted

Nigeria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body weight	Body weight will be measured to the nearest 0.1 kg with a weighing scale	Baseline
Other	Dietary intake of energy, protein, fat, carbohydrates, vitamins and minerals	Group mean intake of macronutrients and micronutrients, assessed by 24h recall	Baseline
Other	Body length	Body length will be measured to the nearest 1 cm with a stadiometer	Baseline
Primary	Vitamin A status	Body retinol pool	28 days
Secondary	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.	28 days
Secondary	Prevalence of inflammation	Percentage of children with C-reactive protein (CRP) >5 mg/L and/or alpha-glycoprotein (AGP) >1 g/L	28 days
Secondary	Serum retinol	Serum concentration of retinol (HPLC)	28 days
Secondary	Blood haemoglobin concentration	Haemoglobin concentration (Quikread)	28 days
Secondary	Ferritin concentration	Serum concentration of ferritin (ELISA)	28 days
Secondary	Soluble transferrin receptor concentration	Serum concentration of soluble transferrin receptor concentration (ELISA)	28 days
Secondary	Retinol binding protein	Serum concentration of retinol binding protein (ELISA)	28 days