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

NCT02996513 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-08-25

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Retinol Isotope Dilution (RID)

13C-retinyl acetate will be administered to subjects in order to assess their body retinol pools

Sponsors & Collaborators

  • University of Ibadan

    collaborator OTHER

  • Newcastle University

    collaborator OTHER

  • University of California, Davis

    collaborator OTHER

  • Penn State University

    collaborator OTHER

  • HarvestPlus

    collaborator OTHER

  • Wageningen University

    lead OTHER

Principal Investigators

  • Alida Melse-Boonstra, PhD · Wageningen University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
36 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2016-12-31
Completion
2017-06-30

Countries

  • Nigeria

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02996513 on ClinicalTrials.gov