<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/NCT01692015</url>
  </required_header>
  <id_info>
    <org_study_id>CLS21</org_study_id>
    <nct_id>NCT01692015</nct_id>
  </id_info>
  <brief_title>Diet and Hereditary Haemorrhagic Telangiectasia</brief_title>
  <official_title>A Questionnaire Study on Diet and Hereditary Haemorrhagic Telangiectasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hereditary Haemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people. The purpose of this&#xD;
      study is to provide data regarding the diet and nosebleed frequency using a questionnaire.&#xD;
&#xD;
      This will be filled in by people with HHT.&#xD;
&#xD;
      The questionnaire has been designed in paper format.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hereditary Haemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people, usually causing&#xD;
      nosebleeds, skin blood spots, and/or anaemia as a result of bleeding from the nose or gut.&#xD;
      The majority of people with HHT also have abnormal blood vessels (arteriovenous&#xD;
      malformations) in internal organs such as the lungs, liver and brain. Management of this&#xD;
      multisystem disorder is highly challenging.&#xD;
&#xD;
      The Lead Applicant has spent 20 years working on this rare disease, and identified multiple&#xD;
      areas where more evidence is required to assist clinicians and patients with this lifelong&#xD;
      condition. A particular issue is whether the diet influences HHT or its complications in any&#xD;
      way.&#xD;
&#xD;
      In this study, people will fill in two questionnaires, one giving details of their diet, and&#xD;
      another details of their nosebleeds. They will also be asked to consider participating in an&#xD;
      accessory study arm which includes weighing food for one week and providing a food diary, in&#xD;
      addition to having a single set of blood test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>April 2011</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dietary food item content</measure>
    <time_frame>1 year</time_frame>
    <description>The European Prospective Investigation into Cancer and Nutrition (EPIC) food frequency questionnaire is used to quantify dietary intake. This method has been validated against the gold standard for dietary assessment, a 7-day weighed food diary. Questions are asked about consumption of 130 major food items over the previous year, requiring participants to indicate the frequency of consumption, and to provide details about the methods of cooking, type of produce, and use of dietary supplements. The EPIC FFQ has been widely validated in a number of studies and is deemed an adequate assessment tool to assess dietary intake.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nosebleed severity</measure>
    <time_frame>3 months</time_frame>
    <description>Nosebleeds were quantified using the validated Epistaxis Severity Score (ESS). The six questions provide an objective measure of nosebleeds: three relate to different characteristics of typical nosebleeds within the previous three months (frequency, duration and intensity (gushing/pouring or not)), three to medical attention, anemia and transfusion requirements</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Hereditary Haemorrhagic Telangiectasia (HHT)</condition>
  <arm_group>
    <arm_group_label>Diet and nosebleed questionnaire</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will only be required to fill in two paper questionnaires, one on dietary history, and one on nosebleed severity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Weighed food diary arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will be required to weigh their food for one week to generate a food dairy, and have a single blood test, in addition to filling in the two paper questionnaires, one on dietary history, and one on nosebleed severity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire on dietary history</intervention_name>
    <arm_group_label>Diet and nosebleed questionnaire</arm_group_label>
    <arm_group_label>Weighed food diary arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire on nosebleed severity</intervention_name>
    <arm_group_label>Diet and nosebleed questionnaire</arm_group_label>
    <arm_group_label>Weighed food diary arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>One week food diary generated by weighing foods</intervention_name>
    <arm_group_label>Weighed food diary arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood tests for full blood count, albumin, and indices of nutritional status</intervention_name>
    <arm_group_label>Weighed food diary arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of hereditary Haemorrhagic Telangiectasia (HHT)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Presence of another major organ disorder that may affect nutritional status, such as&#xD;
             inflammatory bowel disease, or celiac disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire L Shovlin, PhD FRCP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College London</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>HHTIC London, Hammersmith Hospital, Imperial College Healthcare NHS Trust</name>
      <address>
        <city>London</city>
        <zip>W12 0NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <results_reference>
    <citation>Finnamore H, Le Couteur J, Hickson M, Busbridge M, Whelan K, Shovlin CL. Hemorrhage-adjusted iron requirements, hematinics and hepcidin define hereditary hemorrhagic telangiectasia as a model of hemorrhagic iron deficiency. PLoS One. 2013 Oct 16;8(10):e76516. doi: 10.1371/journal.pone.0076516. eCollection 2013.</citation>
    <PMID>24146883</PMID>
  </results_reference>
  <results_reference>
    <citation>Finnamore HE, Whelan K, Hickson M, Shovlin CL. Top dietary iron sources in the UK. Br J Gen Pract. 2014 Apr;64(621):172-3. doi: 10.3399/bjgp14X677761. No abstract available.</citation>
    <PMID>24686867</PMID>
  </results_reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>May 28, 2015</last_update_submitted>
  <last_update_submitted_qc>May 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 29, 2015</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>Telangiectasis</mesh_term>
    <mesh_term>Telangiectasia, Hereditary Hemorrhagic</mesh_term>
  </condition_browse>
  <!-- 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/NCT01692015
org study id: CLS21
nct id: NCT01692015
lead sponsor: 
has dmc: No
Hereditary Haemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people. The purpose of this
      study is to provide data regarding the diet and nosebleed frequency using a questionnaire.

      This will be filled in by people with HHT.

      The questionnaire has been designed in paper format.
Hereditary Haemorrhagic Telangiectasia (HHT) affects 1 in 5,000 people, usually causing
      nosebleeds, skin blood spots, and/or anaemia as a result of bleeding from the nose or gut.
      The majority of people with HHT also have abnormal blood vessels (arteriovenous
      malformations) in internal organs such as the lungs, liver and brain. Management of this
      multisystem disorder is highly challenging.

      The Lead Applicant has spent 20 years working on this rare disease, and identified multiple
      areas where more evidence is required to assist clinicians and patients with this lifelong
      condition. A particular issue is whether the diet influences HHT or its complications in any
      way.

      In this study, people will fill in two questionnaires, one giving details of their diet, and
      another details of their nosebleeds. They will also be asked to consider participating in an
      accessory study arm which includes weighing food for one week and providing a food diary, in
      addition to having a single set of blood test.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Dietary food item content
time frame: 1 year
description: The European Prospective Investigation into Cancer and Nutrition (EPIC) food frequency questionnaire is used to quantify dietary intake. This method has been validated against the gold standard for dietary assessment, a 7-day weighed food diary. Questions are asked about consumption of 130 major food items over the previous year, requiring participants to indicate the frequency of consumption, and to provide details about the methods of cooking, type of produce, and use of dietary supplements. The EPIC FFQ has been widely validated in a number of studies and is deemed an adequate assessment tool to assess dietary intake.
measure: Nosebleed severity
time frame: 3 months
description: Nosebleeds were quantified using the validated Epistaxis Severity Score (ESS). The six questions provide an objective measure of nosebleeds: three relate to different characteristics of typical nosebleeds within the previous three months (frequency, duration and intensity (gushing/pouring or not)), three to medical attention, anemia and transfusion requirements
arm group label: Diet and nosebleed questionnaire
arm group type: Experimental
description: Participants will only be required to fill in two paper questionnaires, one on dietary history, and one on nosebleed severity.
arm group label: Weighed food diary arm
arm group type: Experimental
description: Participants will be required to weigh their food for one week to generate a food dairy, and have a single blood test, in addition to filling in the two paper questionnaires, one on dietary history, and one on nosebleed severity.
intervention type: Other
intervention name: Questionnaire on dietary history
arm group label: Diet and nosebleed questionnaire
arm group label: Weighed food diary arm
intervention type: Other
intervention name: Questionnaire on nosebleed severity
arm group label: Diet and nosebleed questionnaire
arm group label: Weighed food diary arm
intervention type: Other
intervention name: One week food diary generated by weighing foods
arm group label: Weighed food diary arm
intervention type: Procedure
intervention name: Blood tests for full blood count, albumin, and indices of nutritional status
arm group label: Weighed food diary arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Claire L Shovlin, PhD FRCP
role: Principal Investigator
affiliation: Imperial College London
facility: 
country: United Kingdom
citation: Finnamore H, Le Couteur J, Hickson M, Busbridge M, Whelan K, Shovlin CL. Hemorrhage-adjusted iron requirements, hematinics and hepcidin define hereditary hemorrhagic telangiectasia as a model of hemorrhagic iron deficiency. PLoS One. 2013 Oct 16;8(10):e76516. doi: 10.1371/journal.pone.0076516. eCollection 2013.
PMID: 24146883
citation: Finnamore HE, Whelan K, Hickson M, Shovlin CL. Top dietary iron sources in the UK. Br J Gen Pract. 2014 Apr;64(621):172-3. doi: 10.3399/bjgp14X677761. No abstract available.
PMID: 24686867
responsible party type: Sponsor
mesh term: Telangiectasis
mesh term: Telangiectasia, Hereditary Hemorrhagic