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

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ClinicalTrials.gov Identifier: NCT02996513
Recruitment Status : Completed
First Posted : December 19, 2016
Last Update Posted : August 25, 2017
Sponsor:
Collaborators:
University of Ibadan
Newcastle University
University of California, Davis
Penn State University
HarvestPlus
Information provided by (Responsible Party):
Wageningen University

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.

Condition or disease Intervention/treatment Phase
Vitamin A Deficiency Malaria Inflammation Other: Retinol Isotope Dilution (RID) Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : October 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria Vitamin A

Arm Intervention/treatment
Experimental: Retinol Isotope dilution (RID)
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




Primary Outcome Measures :
  1. Vitamin A status [ Time Frame: 28 days ]
    Body retinol pool


Secondary Outcome Measures :
  1. Prevalence of malaria (plasmodium falciparum) [ Time Frame: 28 days ]
    Percentage of children with malaria (Plasmodium falciparum) as determined by a rapid test (CareStart Malaria HRP2) and confirmed by PCR.

  2. Prevalence of inflammation [ Time Frame: 28 days ]
    Percentage of children with C-reactive protein (CRP) >5 mg/L and/or alpha-glycoprotein (AGP) >1 g/L

  3. Serum retinol [ Time Frame: 28 days ]
    Serum concentration of retinol (HPLC)

  4. Blood haemoglobin concentration [ Time Frame: 28 days ]
    Haemoglobin concentration (Quikread)

  5. Ferritin concentration [ Time Frame: 28 days ]
    Serum concentration of ferritin (ELISA)

  6. Soluble transferrin receptor concentration [ Time Frame: 28 days ]
    Serum concentration of soluble transferrin receptor concentration (ELISA)

  7. Retinol binding protein [ Time Frame: 28 days ]
    Serum concentration of retinol binding protein (ELISA)


Other Outcome Measures:
  1. Body weight [ Time Frame: Baseline ]
    Body weight will be measured to the nearest 0.1 kg with a weighing scale

  2. Dietary intake of energy, protein, fat, carbohydrates, vitamins and minerals [ Time Frame: Baseline ]
    Group mean intake of macronutrients and micronutrients, assessed by 24h recall

  3. Body length [ Time Frame: Baseline ]
    Body length will be measured to the nearest 1 cm with a stadiometer



Information from the National Library of Medicine

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Ages Eligible for Study:   36 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02996513


Locations
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Nigeria
University of Ibadan
Ibadan, Oyo State, Nigeria
Sponsors and Collaborators
Wageningen University
University of Ibadan
Newcastle University
University of California, Davis
Penn State University
HarvestPlus
Investigators
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Principal Investigator: Alida Melse-Boonstra, PhD Wageningen University

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Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT02996513     History of Changes
Other Study ID Numbers: WageningenU
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Wageningen University:
Vitamin A status
Retinol Isotope Dilution
Nigeria
Preschool children
Malaria
Inflammation

Additional relevant MeSH terms:
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Inflammation
Malaria
Vitamin A Deficiency
Night Blindness
Pathologic Processes
Protozoan Infections
Parasitic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamin A
Retinol palmitate
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents