xml: <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/NCT06028607</url>
    </required_header>
    <id_info>
      <org_study_id>Version 1.0</org_study_id>
      <nct_id>NCT06028607</nct_id>
    </id_info>
    <brief_title>Feasibility of Consumption of Nutritional Supplementation in Primary Ciliary Dyskinesia</brief_title>
    <acronym>(PCD)</acronym>
    <official_title>A Study to Explore the Feasibility of Consumption of Specific Complex Amino Acid Supplementation in the Form of an Oral Gel With Additional Leucine (40%) and Vitamin D in Patients With Primary Ciliary Dyskinesia: a Feasibility Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Leeds</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Leeds</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Feasibility study to understand and gain preliminary information on tolerability and&#xD;
        palatability of an oral nutritional supplement gel in a clinical Primary Ciliary Dyskinesia&#xD;
        population. To determine if dietary intake is affected by the consumption of the nutritional&#xD;
        supplement.&#xD;
  &#xD;
        Explore possible future outcome measures that could be important in determining impact of&#xD;
        this nutritional intervention on this patient group.&#xD;
  &#xD;
        Participants will be provided with the gel supplements and alongside will have other standard&#xD;
        and non standard care measures assessed lung function (FEV1%) number of exacerbation's during&#xD;
        study period vitamin D status Bio impedance analysis (BIA) skin-fold measures (e.g. Tricep&#xD;
        Skin-fold (TSF) Mid upper arm circumference (MUAC) Handgrip strength (HGS) quality of life&#xD;
        measures 6-minute walking tests. Hypothesis Patients with PCD can successfully consume 2 gel&#xD;
        supplements per day for a period of 3 months with no effect on dietary intake.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single site study taking place in a regional PCD clinic. Participants are screened&#xD;
        via patient online data system by lead consultants and contacted via telephone to outline&#xD;
        study and provide information and contact for queries. participant information sheet and&#xD;
        pre-test guidance to be sent to participant prior to next scheduled clinic appointment.&#xD;
  &#xD;
        Participants attend their usual clinic appointments where routine care measures are completed&#xD;
        by healthcare assistants and lead consultants. They then have opportunity to ask study&#xD;
        coordinator any questions and complete consent for additional measures to be recorded.&#xD;
  &#xD;
        This is followed by a trial of the supplement to check for immediate tolerance followed by&#xD;
        completion of consent to partake in study and initial palatability and acceptability records.&#xD;
  &#xD;
        3 month supply of supplement is provided along with storage and consumption instructions&#xD;
        (consume 1 at breakfast and 1 at lunch) a waste box to retain consumed sachets and record&#xD;
        time of consumption. Additional telephone appointment made for 1 month to collect further&#xD;
        palatability and acceptability along with dietary 24 hour recall.&#xD;
  &#xD;
        Participant is contacted via telephone at month 1 and 2 to recheck tolerability,&#xD;
        acceptability, palatability and dietary intake. Participant can withdraw at any time if&#xD;
        unable to continue to tolerate gel supplement.&#xD;
  &#xD;
        Participant returns to clinic at month 3 to repeat all standard measures, additional outcomes&#xD;
        and palatability, acceptability and dietary intake.&#xD;
  &#xD;
        participant has completed study offered further dietary support through usual clinic route&#xD;
        with registered dietitian.&#xD;
  &#xD;
        Participants can withdraw from the study at any point without giving any reason. Any data&#xD;
        collected from them up until that point can be used in analysis.&#xD;
  &#xD;
        As this is a feasibility study a sample size calculation is not required. The PCD population&#xD;
        within the regional clinic at time of recruitment is 54. All patients with PCD will be&#xD;
        approached for inclusion in this feasibility if they meet the inclusion criteria until&#xD;
        minimum number of 15 and maximum of 20 is reached.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 17, 2021</start_date>
    <completion_date type="Actual">February 28, 2022</completion_date>
    <primary_completion_date type="Actual">November 29, 2021</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>
      <intervention_model_description>All service users will be approached for inclusion in feasibility</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage consumption of supplement gels</measure>
      <time_frame>3 months</time_frame>
      <description>To measure through percentage (%) consumed by return of empty sachets over period of three months for each participant</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of palatability of supplement gels</measure>
      <time_frame>3 months</time_frame>
      <description>To measure using hedonic rating scale (like a lot, like a little, neither like nor dislike, dislike a little, dislike a lot) the appearance, aroma, taste, sweetness, texture mouth feel over the study period of 3 months for each participant</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Measurement of dietary intake</measure>
      <time_frame>3 months</time_frame>
      <description>To collect dietary intake at monthly intervals (baseline, one, two and three) using multiple pass 24 hour recalls conducted through face to face and telephone interviews at each time point recording all food and drink consumption. This is then analysed via Nutritics software, for each participant</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Lung Function (Forced Expiratory Volume1 %, Forced Vital Capacity %)</measure>
      <time_frame>3 months</time_frame>
      <description>Determine if any changes occur during 3-month period of supplementation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Body Mass Index</measure>
      <time_frame>3 months</time_frame>
      <description>Weight and height will be combined to report BMI in kg/m2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Medical Research Council (MRC) breathlessness score</measure>
      <time_frame>3 months</time_frame>
      <description>Will be assessed at initial and end points using the degree of breathlessness related activity. Scale is 1-5 (not troubled by breathless except on strenuous exercise to too breathless to leave the house or breathless when dressing and undressing) therefore the higher the score the worse the outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Vitamin D levels</measure>
      <time_frame>3 months</time_frame>
      <description>To determine any changes during supplementation period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of infections over study period</measure>
      <time_frame>3 months</time_frame>
      <description>Recorded as part of routine care the number of infections requiring antibiotic treatment either intravenous or oral) over the study period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life outcome SF-36 questionnaire</measure>
      <time_frame>3 months</time_frame>
      <description>Completion of SF-36 quality of life questionnaire questionnaire which is used to determine generic health concepts of functional status and wellbeing. Completed at baseline and end of study period. The higher the score the better the health outcomes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life outcome St Georges Respiratory Questionnaire</measure>
      <time_frame>3 months</time_frame>
      <description>Completion of St Georges Respiratory questionnaire designed to measure health impairment in respiratory conditions. The results are calculated out of 100 with 100 being the worst possible outcomes and 0 the best.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Habitual activity estimation scale (HAES)</measure>
      <time_frame>3 months</time_frame>
      <description>HAES scale which establishes daily activity levels at baseline and end of study for one typical weekday and one typical weekend day and using percentage of time spent on those activities out of 100%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hand grip strength dynamometry</measure>
      <time_frame>3 months</time_frame>
      <description>Measurement of muscle functionality using hand grip dynamometer recorded as kg/f (kilograms of force)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tricep skinfold measure</measure>
      <time_frame>3 months</time_frame>
      <description>To determine any changes during supplementation period. Measured in millimetres using Harpenden skinfold calipers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mid upper arm circumference</measure>
      <time_frame>3 months</time_frame>
      <description>To determine any changes during supplementation period measured in centimetres, measured using an identified mid point between the acromion and olecranon processes using a tape measure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Six minute walk tests</measure>
      <time_frame>3 months</time_frame>
      <description>To determine any changes during supplementation period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bio electrical impedance analysis</measure>
      <time_frame>3 months</time_frame>
      <description>Measure the electrical resistance of tissue to determine skeletal muscle mass reported as percentages and kilograms of participants at baseline and end point</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bio electrical impedance analysis</measure>
      <time_frame>3 months</time_frame>
      <description>Measure the electrical resistance of tissue to determine fat mass (FM), reported as percentages and kilograms of participants at baseline and end point</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bio electrical impedance analysis</measure>
      <time_frame>3 months</time_frame>
      <description>Measure the electrical resistance of tissue to determine fat free mass (FFM) reported as percentages and kilograms of participants at baseline and end point</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">15</enrollment>
    <condition>Primary Ciliary Dyskinesia</condition>
    <arm_group>
      <arm_group_label>Study Population</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Participants will be recruited and consented as part of routine care. All will trial supplement initially and have standard and additional measures taken. they will be followed up at month 1 and 2 collecting the primary outcomes (acceptability/palatability and dietary intake) and all initial measures repeated at month 3.&#xD;
  Each participant will receive 3 months supply of gels to consume 2 per day.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>QD-27</intervention_name>
      <description>Oral Protein gel with greater Leucine proportion and vitamin D Consumption of 2 each day for 3 months to be taken at breakfast and lunch</description>
      <arm_group_label>Study Population</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  People aged 17 or over with a confirmed diagnosis of Primary ciliary dyskinesia PCD&#xD;
               (nasal brushings)&#xD;
  &#xD;
            -  People who attend the Leeds Regional PCD Clinics&#xD;
  &#xD;
            -  People who have capacity to give informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  People who are pregnant&#xD;
  &#xD;
            -  Those with existing co-morbidities such as malignancy&#xD;
  &#xD;
            -  People with connective tissue disorders and immunoglobulin deficiencies&#xD;
  &#xD;
            -  People with renal insufficiency r&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>17 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Daniel G Peckham</last_name>
      <role>Principal Investigator</role>
      <affiliation>Univeristy Of Leeds</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>University of Leeds</name>
        <address>
          <city>Leeds</city>
          <state>West Yorkshire</state>
          <zip>LS2 9NL</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <reference>
      <citation>Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.</citation>
      <PMID>11124729</PMID>
    </reference>
    <reference>
      <citation>Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991 Sep;85 Suppl B:25-31; discussion 33-7. doi: 10.1016/s0954-6111(06)80166-6.</citation>
      <PMID>1759018</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Leeds</investigator_affiliation>
      <investigator_full_name>Professor Daniel G Peckham</investigator_full_name>
      <investigator_title>Professor of Respiratory Medicine</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ciliary Motility Disorders</mesh_term>
      <mesh_term>Dyskinesias</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06028607
  org study id: Version 1.0
  nct id: NCT06028607
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Feasibility study to understand and gain preliminary information on tolerability and
        palatability of an oral nutritional supplement gel in a clinical Primary Ciliary Dyskinesia
        population. To determine if dietary intake is affected by the consumption of the nutritional
        supplement.
  
        Explore possible future outcome measures that could be important in determining impact of
        this nutritional intervention on this patient group.
  
        Participants will be provided with the gel supplements and alongside will have other standard
        and non standard care measures assessed lung function (FEV1%) number of exacerbation's during
        study period vitamin D status Bio impedance analysis (BIA) skin-fold measures (e.g. Tricep
        Skin-fold (TSF) Mid upper arm circumference (MUAC) Handgrip strength (HGS) quality of life
        measures 6-minute walking tests. Hypothesis Patients with PCD can successfully consume 2 gel
        supplements per day for a period of 3 months with no effect on dietary intake.
  This is a single site study taking place in a regional PCD clinic. Participants are screened
        via patient online data system by lead consultants and contacted via telephone to outline
        study and provide information and contact for queries. participant information sheet and
        pre-test guidance to be sent to participant prior to next scheduled clinic appointment.
  
        Participants attend their usual clinic appointments where routine care measures are completed
        by healthcare assistants and lead consultants. They then have opportunity to ask study
        coordinator any questions and complete consent for additional measures to be recorded.
  
        This is followed by a trial of the supplement to check for immediate tolerance followed by
        completion of consent to partake in study and initial palatability and acceptability records.
  
        3 month supply of supplement is provided along with storage and consumption instructions
        (consume 1 at breakfast and 1 at lunch) a waste box to retain consumed sachets and record
        time of consumption. Additional telephone appointment made for 1 month to collect further
        palatability and acceptability along with dietary 24 hour recall.
  
        Participant is contacted via telephone at month 1 and 2 to recheck tolerability,
        acceptability, palatability and dietary intake. Participant can withdraw at any time if
        unable to continue to tolerate gel supplement.
  
        Participant returns to clinic at month 3 to repeat all standard measures, additional outcomes
        and palatability, acceptability and dietary intake.
  
        participant has completed study offered further dietary support through usual clinic route
        with registered dietitian.
  
        Participants can withdraw from the study at any point without giving any reason. Any data
        collected from them up until that point can be used in analysis.
  
        As this is a feasibility study a sample size calculation is not required. The PCD population
        within the regional clinic at time of recruitment is 54. All patients with PCD will be
        approached for inclusion in this feasibility if they meet the inclusion criteria until
        minimum number of 15 and maximum of 20 is reached.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: All service users will be approached for inclusion in feasibility
  primary purpose: Other
  masking: None (Open Label)
  measure: Percentage consumption of supplement gels
  time frame: 3 months
  description: To measure through percentage (%) consumed by return of empty sachets over period of three months for each participant
  measure: Assessment of palatability of supplement gels
  time frame: 3 months
  description: To measure using hedonic rating scale (like a lot, like a little, neither like nor dislike, dislike a little, dislike a lot) the appearance, aroma, taste, sweetness, texture mouth feel over the study period of 3 months for each participant
  measure: Measurement of dietary intake
  time frame: 3 months
  description: To collect dietary intake at monthly intervals (baseline, one, two and three) using multiple pass 24 hour recalls conducted through face to face and telephone interviews at each time point recording all food and drink consumption. This is then analysed via Nutritics software, for each participant
  measure: Lung Function (Forced Expiratory Volume1 %, Forced Vital Capacity %)
  time frame: 3 months
  description: Determine if any changes occur during 3-month period of supplementation
  measure: Body Mass Index
  time frame: 3 months
  description: Weight and height will be combined to report BMI in kg/m2
  measure: Medical Research Council (MRC) breathlessness score
  time frame: 3 months
  description: Will be assessed at initial and end points using the degree of breathlessness related activity. Scale is 1-5 (not troubled by breathless except on strenuous exercise to too breathless to leave the house or breathless when dressing and undressing) therefore the higher the score the worse the outcome
  measure: Vitamin D levels
  time frame: 3 months
  description: To determine any changes during supplementation period
  measure: Number of infections over study period
  time frame: 3 months
  description: Recorded as part of routine care the number of infections requiring antibiotic treatment either intravenous or oral) over the study period
  measure: Quality of life outcome SF-36 questionnaire
  time frame: 3 months
  description: Completion of SF-36 quality of life questionnaire questionnaire which is used to determine generic health concepts of functional status and wellbeing. Completed at baseline and end of study period. The higher the score the better the health outcomes
  measure: Quality of Life outcome St Georges Respiratory Questionnaire
  time frame: 3 months
  description: Completion of St Georges Respiratory questionnaire designed to measure health impairment in respiratory conditions. The results are calculated out of 100 with 100 being the worst possible outcomes and 0 the best.
  measure: Habitual activity estimation scale (HAES)
  time frame: 3 months
  description: HAES scale which establishes daily activity levels at baseline and end of study for one typical weekday and one typical weekend day and using percentage of time spent on those activities out of 100%.
  measure: Hand grip strength dynamometry
  time frame: 3 months
  description: Measurement of muscle functionality using hand grip dynamometer recorded as kg/f (kilograms of force)
  measure: Tricep skinfold measure
  time frame: 3 months
  description: To determine any changes during supplementation period. Measured in millimetres using Harpenden skinfold calipers
  measure: Mid upper arm circumference
  time frame: 3 months
  description: To determine any changes during supplementation period measured in centimetres, measured using an identified mid point between the acromion and olecranon processes using a tape measure
  measure: Six minute walk tests
  time frame: 3 months
  description: To determine any changes during supplementation period
  measure: Bio electrical impedance analysis
  time frame: 3 months
  description: Measure the electrical resistance of tissue to determine skeletal muscle mass reported as percentages and kilograms of participants at baseline and end point
  measure: Bio electrical impedance analysis
  time frame: 3 months
  description: Measure the electrical resistance of tissue to determine fat mass (FM), reported as percentages and kilograms of participants at baseline and end point
  measure: Bio electrical impedance analysis
  time frame: 3 months
  description: Measure the electrical resistance of tissue to determine fat free mass (FFM) reported as percentages and kilograms of participants at baseline and end point
  arm group label: Study Population
  arm group type: Other
  description: Participants will be recruited and consented as part of routine care. All will trial supplement initially and have standard and additional measures taken. they will be followed up at month 1 and 2 collecting the primary outcomes (acceptability/palatability and dietary intake) and all initial measures repeated at month 3.
  Each participant will receive 3 months supply of gels to consume 2 per day.
  intervention type: Dietary Supplement
  intervention name: QD-27
  description: Oral Protein gel with greater Leucine proportion and vitamin D Consumption of 2 each day for 3 months to be taken at breakfast and lunch
  arm group label: Study Population
  criteria: 
  gender: All
  minimum age: 17 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Daniel G Peckham
  role: Principal Investigator
  affiliation: Univeristy Of Leeds
  facility: 
  country: United Kingdom
  citation: Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.
  PMID: 11124729
  citation: Jones PW, Quirk FH, Baveystock CM. The St George's Respiratory Questionnaire. Respir Med. 1991 Sep;85 Suppl B:25-31; discussion 33-7. doi: 10.1016/s0954-6111(06)80166-6.
  PMID: 1759018
  responsible party type: Principal Investigator
  investigator affiliation: University of Leeds
  investigator full name: Professor Daniel G Peckham
  investigator title: Professor of Respiratory Medicine
  mesh term: Ciliary Motility Disorders
  mesh term: Dyskinesias
  sharing ipd: No