Diet and Hereditary Haemorrhagic Telangiectasia

Imperial College London

Status: Completed

Conditions: Hereditary Haemorrhagic Telangiectasia (HHT)

Treatments: 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; Other: Questionnaire on dietary history

Study type: Interventional

Funder types: Other

Identifiers

NCT01692015

CLS21

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Diet and nosebleed questionnaire

Experimental group

Description:

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

Treatment:

Other: Questionnaire on dietary history

Other: Questionnaire on nosebleed severity

Weighed food diary arm

Experimental group

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.

Treatment:

Other: Questionnaire on dietary history

Other: One week food diary generated by weighing foods

Other: Questionnaire on nosebleed severity

Procedure: Blood tests for full blood count, albumin, and indices of nutritional status