Completed

A Questionnaire Study on Diet and Hereditary Haemorrhagic Telangiectasia

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What is being tested

Questionnaire on dietary history

+ Questionnaire on nosebleed severity

+ Questionnaire on dietary history

OtherProcedure
Who is being recruted

Congenital Abnormalities+18

+ Cardiovascular Diseases

+ Hematologic Diseases

Over 18 Years
+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: April 2011
See protocol details

Summary

Principal SponsorImperial College London
Last updated: March 29, 2024
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01692015
Principal SponsorImperial College London
Last updated: March 29, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Congenital AbnormalitiesCardiovascular DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemorrhageHemorrhagic DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNose DiseasesOtorhinolaryngologic DiseasesPathologic ProcessesRespiratory Tract DiseasesSigns and SymptomsSigns and Symptoms, RespiratoryPathological Conditions, Signs and SymptomsTelangiectasisVascular DiseasesCardiovascular AbnormalitiesHemostatic DisordersVascular MalformationsEpistaxisTelangiectasia, Hereditary Hemorrhagic

Criteria

1 inclusion criteria required to participate
A diagnosis of hereditary Haemorrhagic Telangiectasia (HHT)
2 exclusion criteria prevent from participating
Presence of another major organ disorder that may affect nutritional status, such as inflammatory bowel disease, or celiac disease
Unable to provide informed consent

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Experimental
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 Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

HHTIC London, Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, United KingdomOpen HHTIC London, Hammersmith Hospital, Imperial College Healthcare NHS Trust in Google Maps
CompletedOne Study Center