<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02996513</url>
  </required_header>
  <id_info>
    <org_study_id>WageningenU</org_study_id>
    <nct_id>NCT02996513</nct_id>
  </id_info>
  <brief_title>Assessing Model Parameters for Applying the Retinol Isotope Dilution (RID) Method</brief_title>
  <acronym>SUPERKID</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wageningen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Ibadan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Newcastle University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of California, Davis</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Penn State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>HarvestPlus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Wageningen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      For assessing body retinol pools in preschool children, it is recommended that a blood sample&#xD;
      is taken 14-21 days after isotope dosing. During this period, dietary intake of vitamin A&#xD;
      should be controlled. Shortening of this period as has been validated for adults would reduce&#xD;
      the burden for the children as well as improve research efficiency. The aim is to validate a&#xD;
      4-day protocol for assessing body retinol pools in preschool children by modelling data&#xD;
      derived by retinol isotope dilution (RID) method. Venous blood samples will be collected of&#xD;
      60 children 4 days after dosing of 0.4 mg 13C-labeled retinyl acetate. A second venous blood&#xD;
      sample will be collected at 6, 8, 12 hrs; and 1, 2, 4, 7, 11, 16, 22 and 28 days after dosing&#xD;
      in subgroups of 6 children, randomly divided over the 10 additional time points. Body retinol&#xD;
      pools will be modelled, and the time point at which a parsimonious model applies (presumably&#xD;
      at day 4) will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For assessing body retinol pools in preschool children, it is recommended that a blood sample&#xD;
      is taken 14-21 days after isotope dosing. During this period, dietary intake of vitamin A&#xD;
      should be controlled. Shortening of this period as has been validated for adults would reduce&#xD;
      the burden for the children as well as improve research efficiency. The aim is to validate a&#xD;
      4-day protocol for assessing body retinol pools in preschool children by modelling data&#xD;
      derived by retinol isotope dilution (RID) method. A secondary aim is to compare body retinol&#xD;
      pools between children with and without inflammation and to assess the effect of asymptomatic&#xD;
      malaria on model parameters. Preschool children (n=60), 36-59 months of age, residing in&#xD;
      Telemu, Osun State, Nigeria will be recruited for the study. The study design is an&#xD;
      observational pre/post study, for which body retinol pools will be measured using the RID&#xD;
      method. Venous blood samples will be collected of all children 4 days after dosing of 0.4 mg&#xD;
      13C-labeled retinyl acetate. A second venous blood sample will be collected at 6, 8, 12 hrs;&#xD;
      and 1, 2, 4, 7, 11, 16, 22 and 28 days after dosing in subgroups of 6 children, randomly&#xD;
      divided over the 10 additional time points. Children presenting with asymptomatic malaria&#xD;
      will be treated, and a convenience subsample (n=10) will undergo a second assessment of body&#xD;
      retinol pools determined with a venous blood collection on day 4 post-dosing only. Body&#xD;
      retinol pools will be modelled, and the time point at which a parsimonious model applies&#xD;
      (presumably at day 4) will be assessed. Presence of asymptomatic malaria and markers of&#xD;
      inflammation will be assessed in all children at all time points. Body retinol pools and&#xD;
      model parameters between subgroups of children with and without asymptomatic malaria and/or&#xD;
      inflammation will be compared. Pre/post comparisons of body retinol pool estimates will be&#xD;
      done for the follow up subsample.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Vitamin A status</measure>
    <time_frame>28 days</time_frame>
    <description>Body retinol pool</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prevalence of malaria (plasmodium falciparum)</measure>
    <time_frame>28 days</time_frame>
    <description>Percentage of children with malaria (Plasmodium falciparum) as determined by a rapid test (CareStart Malaria HRP2) and confirmed by PCR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevalence of inflammation</measure>
    <time_frame>28 days</time_frame>
    <description>Percentage of children with C-reactive protein (CRP) &gt;5 mg/L and/or alpha-glycoprotein (AGP) &gt;1 g/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum retinol</measure>
    <time_frame>28 days</time_frame>
    <description>Serum concentration of retinol (HPLC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood haemoglobin concentration</measure>
    <time_frame>28 days</time_frame>
    <description>Haemoglobin concentration (Quikread)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ferritin concentration</measure>
    <time_frame>28 days</time_frame>
    <description>Serum concentration of ferritin (ELISA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Soluble transferrin receptor concentration</measure>
    <time_frame>28 days</time_frame>
    <description>Serum concentration of soluble transferrin receptor concentration (ELISA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retinol binding protein</measure>
    <time_frame>28 days</time_frame>
    <description>Serum concentration of retinol binding protein (ELISA)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Body weight</measure>
    <time_frame>Baseline</time_frame>
    <description>Body weight will be measured to the nearest 0.1 kg with a weighing scale</description>
  </other_outcome>
  <other_outcome>
    <measure>Dietary intake of energy, protein, fat, carbohydrates, vitamins and minerals</measure>
    <time_frame>Baseline</time_frame>
    <description>Group mean intake of macronutrients and micronutrients, assessed by 24h recall</description>
  </other_outcome>
  <other_outcome>
    <measure>Body length</measure>
    <time_frame>Baseline</time_frame>
    <description>Body length will be measured to the nearest 1 cm with a stadiometer</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Vitamin A Deficiency</condition>
  <condition>Malaria</condition>
  <condition>Inflammation</condition>
  <arm_group>
    <arm_group_label>Retinol Isotope dilution (RID)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A once-off dose of 0.4 mg 13C4-retinyl acetate will be administered to subjects as a capsule</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Retinol Isotope Dilution (RID)</intervention_name>
    <description>13C-retinyl acetate will be administered to subjects in order to assess their body retinol pools</description>
    <arm_group_label>Retinol Isotope dilution (RID)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Apparently healthy&#xD;
&#xD;
          -  Between 36 and 59 months of age&#xD;
&#xD;
          -  Living in the community of Telemu, Osun State, Nigeria, or its neighbouring&#xD;
             communities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active or recent disease with a potential effect on study outcome&#xD;
&#xD;
          -  Hb concentration &lt;70 g/dL&#xD;
&#xD;
          -  Mental state that is incompatible with participation in the study&#xD;
&#xD;
          -  Recent exposure to 13C-retinol stable isotopes&#xD;
&#xD;
          -  Unwillingness to participate by verbal or physical expression&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>36 Months</minimum_age>
    <maximum_age>59 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alida Melse-Boonstra, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wageningen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Ibadan</name>
      <address>
        <city>Ibadan</city>
        <state>Oyo State</state>
        <country>Nigeria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Nigeria</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>August 24, 2017</last_update_submitted>
  <last_update_submitted_qc>August 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vitamin A status</keyword>
  <keyword>Retinol Isotope Dilution</keyword>
  <keyword>Nigeria</keyword>
  <keyword>Preschool children</keyword>
  <keyword>Malaria</keyword>
  <keyword>Inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malaria</mesh_term>
    <mesh_term>Night Blindness</mesh_term>
    <mesh_term>Vitamin A Deficiency</mesh_term>
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin A</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02996513
org study id: WageningenU
nct id: NCT02996513
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Vitamin A status
time frame: 28 days
description: Body retinol pool
measure: Prevalence of malaria (plasmodium falciparum)
time frame: 28 days
description: Percentage of children with malaria (Plasmodium falciparum) as determined by a rapid test (CareStart Malaria HRP2) and confirmed by PCR.
measure: Prevalence of inflammation
time frame: 28 days
description: Percentage of children with C-reactive protein (CRP) >5 mg/L and/or alpha-glycoprotein (AGP) >1 g/L
measure: Serum retinol
time frame: 28 days
description: Serum concentration of retinol (HPLC)
measure: Blood haemoglobin concentration
time frame: 28 days
description: Haemoglobin concentration (Quikread)
measure: Ferritin concentration
time frame: 28 days
description: Serum concentration of ferritin (ELISA)
measure: Soluble transferrin receptor concentration
time frame: 28 days
description: Serum concentration of soluble transferrin receptor concentration (ELISA)
measure: Retinol binding protein
time frame: 28 days
description: Serum concentration of retinol binding protein (ELISA)
measure: Body weight
time frame: Baseline
description: Body weight will be measured to the nearest 0.1 kg with a weighing scale
measure: Dietary intake of energy, protein, fat, carbohydrates, vitamins and minerals
time frame: Baseline
description: Group mean intake of macronutrients and micronutrients, assessed by 24h recall
measure: Body length
time frame: Baseline
description: Body length will be measured to the nearest 1 cm with a stadiometer
arm group label: Retinol Isotope dilution (RID)
arm group type: Experimental
description: A once-off dose of 0.4 mg 13C4-retinyl acetate will be administered to subjects as a capsule
intervention type: Other
intervention name: Retinol Isotope Dilution (RID)
description: 13C-retinyl acetate will be administered to subjects in order to assess their body retinol pools
arm group label: Retinol Isotope dilution (RID)
criteria: 
gender: All
minimum age: 36 Months
maximum age: 59 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Alida Melse-Boonstra, PhD
role: Principal Investigator
affiliation: Wageningen University
facility: 
country: Nigeria
responsible party type: Sponsor
mesh term: Malaria
mesh term: Night Blindness
mesh term: Vitamin A Deficiency
mesh term: Inflammation
mesh term: Vitamin A
sharing ipd: No