Diet and Hereditary Haemorrhagic Telangiectasia

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01692015
First received: September 20, 2012
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Hereditary Haemorrhagic Telangiectasia (HHT)
Other: Questionnaire on dietary history
Other: Questionnaire on nosebleed severity
Other: One week food diary generated by weighing foods
Procedure: Blood tests for full blood count, albumin, and indices of nutritional status

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Questionnaire Study on Diet and Hereditary Haemorrhagic Telangiectasia

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Dietary food item content [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

  • Nosebleed severity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 150
Study Start Date: April 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diet and nosebleed questionnaire
Participants will only be required to fill in two paper questionnaires, one on dietary history, and one on nosebleed severity.
Other: Questionnaire on dietary history Other: Questionnaire on nosebleed severity
Experimental: Weighed food diary arm
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.
Other: Questionnaire on dietary history Other: Questionnaire on nosebleed severity Other: One week food diary generated by weighing foods Procedure: Blood tests for full blood count, albumin, and indices of nutritional status

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A diagnosis of hereditary Haemorrhagic Telangiectasia (HHT)

Exclusion Criteria:

  • Unable to provide informed consent
  • Presence of another major organ disorder that may affect nutritional status, such as inflammatory bowel disease, or celiac disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01692015

Locations
United Kingdom
HHTIC London, Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom, W12 0NN
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Claire L Shovlin, PhD FRCP Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01692015     History of Changes
Other Study ID Numbers: CLS21
Study First Received: September 20, 2012
Last Updated: September 24, 2012
Health Authority: UK: National Research Ethics Service

Additional relevant MeSH terms:
Telangiectasia, Hereditary Hemorrhagic
Telangiectasis
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 10, 2014