Diet and Hereditary Haemorrhagic Telangiectasia
|ClinicalTrials.gov Identifier: NCT01692015|
Recruitment Status : Unknown
Verified September 2012 by Imperial College London.
Recruitment status was: Active, not recruiting
First Posted : September 25, 2012
Last Update Posted : May 29, 2015
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 or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Questionnaire Study on Diet and Hereditary Haemorrhagic Telangiectasia|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2016|
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|
- Dietary food item content [ Time Frame: 1 year ]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 ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01692015
|HHTIC London, Hammersmith Hospital, Imperial College Healthcare NHS Trust|
|London, United Kingdom, W12 0NN|
|Principal Investigator:||Claire L Shovlin, PhD FRCP||Imperial College London|