NCT02996513

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 11, 2016

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 25, 2017

Status Verified

August 1, 2017

Enrollment Period

2 months

First QC Date

November 11, 2016

Last Update Submit

August 24, 2017

Conditions

Vitamin A DeficiencyMalariaInflammation

Keywords

Vitamin A statusRetinol Isotope DilutionNigeriaPreschool childrenMalariaInflammation

Outcome Measures

Primary Outcomes (1)

  • Vitamin A status

    Body retinol pool

    28 days

Secondary Outcomes (7)

  • Prevalence of malaria (plasmodium falciparum)

    28 days

  • Prevalence of inflammation

    28 days

  • Serum retinol

    28 days

  • Blood haemoglobin concentration

    28 days

  • Ferritin concentration

    28 days

  • +2 more secondary outcomes

Other Outcomes (3)

  • Body weight

    Baseline

  • Dietary intake of energy, protein, fat, carbohydrates, vitamins and minerals

    Baseline

  • Body length

    Baseline

Study Arms (1)

Retinol Isotope dilution (RID)

EXPERIMENTAL

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

Other: Retinol Isotope Dilution (RID)

Interventions

Retinol Isotope Dilution (RID)OTHER

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

Retinol Isotope dilution (RID)

Eligibility Criteria

Age36 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Apparently healthy
  • Between 36 and 59 months of age
  • Living in the community of Telemu, Osun State, Nigeria, or its neighbouring communities

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ibadan

Ibadan, Oyo State, Nigeria

Location

MeSH Terms

Conditions

Vitamin A DeficiencyMalariaInflammation

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alida Melse-Boonstra, PhD

    Wageningen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2016

First Posted

December 19, 2016

Study Start

October 1, 2016

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

August 25, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

NG(1)