Skip to main content
OpenTrials
Completed

NCT Number: NCT01692015

Diet and Hereditary Haemorrhagic Telangiectasia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hereditary Haemorrhagic Telangiectasia (HHT) Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Epistaxis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Telangiectasia, Hereditary Hemorrhagic Telangiectasis Vascular Diseases Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HHTIC London, Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, W12 0NN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire on dietary history

Other

Questionnaire on nosebleed severity

Other

One week food diary generated by weighing foods

Other

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

Procedure

Primary outcomes

  1. Number of Participants That Achieving Personal Recommended Intake of Iron

    Time frame: 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.

  2. 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. The final ESS score ranges from 0-10, where a higher score equates to greater blood losses.

  3. Number of Participants That Achieving the Hemorrhage Adjusted Iron Requirement (HAIR)

    Time frame: 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.

Other outcomes

  1. Number of Participants That Ingested Chocolate

    Time frame: 3 months

    Chocolate can precipitate nosebleeds Food items intake assessed by 7-day weighed food diary

  2. Number of Participants That Ingested Bread

    Time frame: 3 months

    Bread not precipitate nosebleeds Food items intake assessed by 7-day weighed food diary

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

A Questionnaire Study on Diet and Hereditary Haemorrhagic Telangiectasia

Important dates

Study start
2011
Primary completion
2013
Study completion
2016
First posted
Sep 25, 2012
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.