Diet and Hereditary Haemorrhagic Telangiectasia

Not Applicable

Completed

• Conditions: Hereditary Haemorrhagic Telangiectasia (HHT)
• Interventions: 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

• Registration Number: NCT01692015
• Lead Sponsor: Imperial College London

Brief Summary

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2012-09-20
• Study First Submitted QC: 2012-09-24
• Study First Posted: 2012-09-25
• Primary Completion: 2013-09
• Study Completion: 2016-09
• Status Verified: 2023-09
• Results First Submitted: 2023-09-25
• Results First Submitted QC: 2023-09-25
• Last Update Submitted: 2023-09-25
• Results First Posted: 2024-03-29
• Last Update Posted: 2024-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• A diagnosis of hereditary Haemorrhagic Telangiectasia (HHT)

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Weighed food diary arm	Questionnaire on dietary history	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.
Diet and nosebleed questionnaire	Questionnaire on dietary history	Participants will only be required to fill in two paper questionnaires, one on dietary history, and one on nosebleed severity.
Weighed food diary arm	One week food diary generated by weighing foods	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.
Diet and nosebleed questionnaire	Questionnaire on nosebleed severity	Participants will only be required to fill in two paper questionnaires, one on dietary history, and one on nosebleed severity.
Weighed food diary arm	Questionnaire on nosebleed severity	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.
Weighed food diary arm	Blood tests for full blood count, albumin, and indices of nutritional status	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.

Primary Outcome Measures

Name	Time	Method
Nosebleed Severity	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. The final ESS score ranges from 0-10, where a higher score equates to greater blood losses.
Number of Participants That Achieving the Hemorrhage Adjusted Iron Requirement (HAIR)	1 year	The hemorrhage-adjusted iron requirement (HAIR) was calculated as the sum of the normal recommended dietary iron intake, and requirements to compensate for non-menstrual blood losses.
Number of Participants That Achieving Personal Recommended Intake of Iron	1 year	Dietary food item iron content assessed by the European Prospective Investigation into Cancer and Nutrition (EPIC) food frequency questionnaire. 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.

Trial Locations

Locations (1)

HHTIC London, Hammersmith Hospital, Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom