<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/NCT02229318</url>
  </required_header>
  <id_info>
    <org_study_id>NA-FRV-012014-01</org_study_id>
    <nct_id>NCT02229318</nct_id>
  </id_info>
  <brief_title>A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.</brief_title>
  <acronym>FruitiVits</acronym>
  <official_title>A Taste and Acceptance Study of FruitiVits, for Use in the Dietary Management of Young Children Requiring Very Restrictive Diets Such as the Ketogenic Diet.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vitaflo International, Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vitaflo International, Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects will be asked to substitute their usual vitamin and mineral supplement/s with&#xD;
      FruitiVits for seven consecutive days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will involve 12 subjects between 4 and 8 years of age, who routinely use&#xD;
      comprehensive micronutrient supplementation as part of their dietary management.&#xD;
&#xD;
      Primary Hypothesis:&#xD;
&#xD;
      FruitiVits is an acceptable source of vitamin, mineral and trace elements for patients on a&#xD;
      Ketogenic diet.&#xD;
&#xD;
      Secondary Hypothesis:&#xD;
&#xD;
      FruitiVits will be well accepted and tolerated when given orally to children on a Ketogenic&#xD;
      diet.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Acceptability of FruitiVits</measure>
    <time_frame>Day 8 of trial</time_frame>
    <description>The study product was rated on a scale of 1-5:&#xD;
(liked very much)&#xD;
(liked moderately)&#xD;
(neither liked nor disliked)&#xD;
(disliked moderately)&#xD;
(disliked very much).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Ease of Preparation of FruitiVits</measure>
    <time_frame>Day 8 of trial</time_frame>
    <description>Ease of preparation of FruitiVits was rated on a scale of 1-5:&#xD;
(very easy)&#xD;
(moderately easy)&#xD;
(neither easy nor difficult)&#xD;
(moderately difficult)&#xD;
(very difficult).&#xD;
Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Seizure Disorders</condition>
  <arm_group>
    <arm_group_label>FruitiVits</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily administration of FruitiVits dietary supplement</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>FruitiVits</intervention_name>
    <description>Daily administration of FruitiVits dietary supplement</description>
    <arm_group_label>FruitiVits</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of condition requiring a Ketogenic diet&#xD;
&#xD;
          2. Currently on a Ketogenic diet&#xD;
&#xD;
          3. Aged 4 - 8 years&#xD;
&#xD;
          4. Routinely taking a complete micronutrient supplement&#xD;
&#xD;
          5. Oral feeding&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1) Children aged less than 4 years or older than 9 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina Bergqvist, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital of Philadelphia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Children's Hospital of Philadelphia, Division of Neurology</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <results_first_submitted>September 7, 2015</results_first_submitted>
  <results_first_submitted_qc>August 15, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 7, 2016</results_first_posted>
  <last_update_submitted>April 30, 2019</last_update_submitted>
  <last_update_submitted_qc>April 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Children between the ages of 4 and 8 years, attending the Ketogenic Diet Center at The Children's Hospital of Philadelphia were invited by email to attend a study family day held on a Saturday afternoon in September 2014. The first 12 families to respond were contacted via telephone and invited to enroll in the study.</recruitment_details>
      <pre_assignment_details>12 families invited to participate, one subject failed to attend the recruitment family day and did not enroll in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>FruitiVits</title>
          <description>Daily administration of FruitiVits dietary supplement</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11">September 6th 2014 11 enrolled</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11">September 15th 2014 11 completed</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>FruitiVits</title>
          <description>Daily administration of FruitiVits dietary supplement</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.7" lower_limit="4.3" upper_limit="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Acceptability of FruitiVits</title>
        <description>The study product was rated on a scale of 1-5:&#xD;
(liked very much)&#xD;
(liked moderately)&#xD;
(neither liked nor disliked)&#xD;
(disliked moderately)&#xD;
(disliked very much).</description>
        <time_frame>Day 8 of trial</time_frame>
        <population>Children aged 4 to 8 years.</population>
        <group_list>
          <group group_id="O1">
            <title>FruitiVits</title>
            <description>Daily administration of FruitiVits dietary supplement</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability of FruitiVits</title>
          <description>The study product was rated on a scale of 1-5:&#xD;
(liked very much)&#xD;
(liked moderately)&#xD;
(neither liked nor disliked)&#xD;
(disliked moderately)&#xD;
(disliked very much).</description>
          <population>Children aged 4 to 8 years.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Appearance score 1-3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Smell score 1-3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Taste score 1-3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Texture score 1-3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ease of Preparation of FruitiVits</title>
        <description>Ease of preparation of FruitiVits was rated on a scale of 1-5:&#xD;
(very easy)&#xD;
(moderately easy)&#xD;
(neither easy nor difficult)&#xD;
(moderately difficult)&#xD;
(very difficult).&#xD;
Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients</description>
        <time_frame>Day 8 of trial</time_frame>
        <population>Children aged 4 to 8 years.</population>
        <group_list>
          <group group_id="O1">
            <title>FruitiVits</title>
            <description>Administration of FruitiVits dietary supplement</description>
          </group>
        </group_list>
        <measure>
          <title>Ease of Preparation of FruitiVits</title>
          <description>Ease of preparation of FruitiVits was rated on a scale of 1-5:&#xD;
(very easy)&#xD;
(moderately easy)&#xD;
(neither easy nor difficult)&#xD;
(moderately difficult)&#xD;
(very difficult).&#xD;
Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients</description>
          <population>Children aged 4 to 8 years.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>7 days per patient</time_frame>
      <desc>A symptom diary was completed for each patient specifically asking about the following:&#xD;
Nausea and/or vomiting Diarrhea and/or constipation Gas, flatulence and/or regurgitation Abdominal bloating and/or distention Abdominal discomfort and/or pain</desc>
      <group_list>
        <group group_id="E1">
          <title>FruitiVits</title>
          <description>Daily administration of FruitiVits dietary supplement</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Christina Bergqvist, M.D., Study Principal Investigator</name_or_title>
      <organization>The Children's Hospital of Philadelphia</organization>
      <phone>+1 215 590 1719</phone>
      <email>Bergqvist@Email.CHoP.Edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02229318
org study id: NA-FRV-012014-01
nct id: NCT02229318
lead sponsor: 
collaborator: 
has dmc: No
Subjects will be asked to substitute their usual vitamin and mineral supplement/s with
      FruitiVits for seven consecutive days.
The study will involve 12 subjects between 4 and 8 years of age, who routinely use
      comprehensive micronutrient supplementation as part of their dietary management.

      Primary Hypothesis:

      FruitiVits is an acceptable source of vitamin, mineral and trace elements for patients on a
      Ketogenic diet.

      Secondary Hypothesis:

      FruitiVits will be well accepted and tolerated when given orally to children on a Ketogenic
      diet.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Acceptability of FruitiVits
time frame: Day 8 of trial
description: The study product was rated on a scale of 1-5:
(liked very much)
(liked moderately)
(neither liked nor disliked)
(disliked moderately)
(disliked very much).
measure: Ease of Preparation of FruitiVits
time frame: Day 8 of trial
description: Ease of preparation of FruitiVits was rated on a scale of 1-5:
(very easy)
(moderately easy)
(neither easy nor difficult)
(moderately difficult)
(very difficult).
Those who considered it not difficult to prepare and scored 1-3 on the scale: 11/11 patients
arm group label: FruitiVits
arm group type: Experimental
description: Daily administration of FruitiVits dietary supplement
intervention type: Dietary Supplement
intervention name: FruitiVits
description: Daily administration of FruitiVits dietary supplement
arm group label: FruitiVits
criteria: 
gender: All
minimum age: 4 Years
maximum age: 9 Years
healthy volunteers: No
last name: Christina Bergqvist, M.D
role: Principal Investigator
affiliation: Children's Hospital of Philadelphia
facility: 
country: United States
responsible party type: Sponsor
mesh term: Seizures
mesh term: Epilepsy
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 