Diet and Hereditary Haemorrhagic Telangiectasia

A Questionnaire Study on Diet and Hereditary Haemorrhagic Telangiectasia

Sponsors

Lead Sponsor: Imperial College London

Source 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.

Overall Status Unknown status
Start Date April 2011
Completion Date September 2016
Primary Completion Date September 2013
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Dietary food item content 1 year
Nosebleed severity 3 months
Enrollment 150
Condition
Intervention

Intervention Type: Other

Intervention Name: Questionnaire on dietary history

Intervention Type: Other

Intervention Name: Questionnaire on nosebleed severity

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

Eligibility

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Claire L Shovlin, PhD FRCP Principal Investigator Imperial College London
Location
Facility: HHTIC London, Hammersmith Hospital, Imperial College Healthcare NHS Trust
Location Countries

United Kingdom

Verification Date

September 2012

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Diet and nosebleed questionnaire

Type: Experimental

Description: Participants will only be required to fill in two paper questionnaires, one on dietary history, and one on nosebleed severity.

Label: Weighed food diary arm

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.

Study Design Info

Allocation: Non-Randomized

Intervention Model: Single Group Assignment

Primary Purpose: Supportive Care

Masking: None (Open Label)

Source: ClinicalTrials.gov