Overview

This trial is active, not recruiting.

Condition hereditary haemorrhagic telangiectasia (hht)
Treatments questionnaire on dietary history, questionnaire on nosebleed severity, one week food diary generated by weighing foods, blood tests for full blood count, albumin, and indices of nutritional status
Sponsor Imperial College London
Start date April 2011
End date September 2013
Trial size 150 participants
Trial identifier NCT01692015, CLS21

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Participants will only be required to fill in two paper questionnaires, one on dietary history, and one on nosebleed severity.
questionnaire on dietary history
questionnaire on nosebleed severity
(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.
questionnaire on dietary history
questionnaire on nosebleed severity
one week food diary generated by weighing foods
blood tests for full blood count, albumin, and indices of nutritional status

Primary Outcomes

Measure
Dietary food item content
time frame: 1 year
Nosebleed severity
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Questionnaire Study on Diet and Hereditary Haemorrhagic Telangiectasia
Principal investigator Claire L Shovlin, PhD FRCP
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Imperial College London.