An interventional study of Questionnaire on dietary history and Questionnaire on nosebleed severity in Hereditary Haemorrhagic Telangiectasia (HHT), sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-29.
Sponsored by Imperial College London · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
Participants will only be required to fill in two paper questionnaires, one on dietary history, and one on nosebleed severity.
Other: Questionnaire on dietary history · Other: Questionnaire on nosebleed severity
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.
Other: Questionnaire on dietary history · 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
Number of Participants That Achieving Personal Recommended Intake of Iron
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.
Time frame: 1 year
Nosebleed Severity
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.
Time frame: 3 months
Number of Participants That Achieving the Hemorrhage Adjusted Iron Requirement (HAIR)
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.
Time frame: 1 year
Number of Participants That Ingested Chocolate
Chocolate can precipitate nosebleeds Food items intake assessed by 7-day weighed food diary
Time frame: 3 months
Number of Participants That Ingested Bread
Bread not precipitate nosebleeds Food items intake assessed by 7-day weighed food diary
Time frame: 3 months
| Milestone | Hereditary Hemorrhagic Telangiectasia (HHT) |
|---|---|
| Started | 50 |
| Completed | 50 |
| Not completed | 0 |
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.
| Participants | Hereditary Hemorrhagic Telangiectasia (HHT) |
|---|---|
| Number of Participants That Achieving Personal Recommended Intake of Iron | 43 |
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.
| units | Hereditary Hemorrhagic Telangiectasia (HHT) |
|---|---|
| Nosebleed Severity | 4.4 (0 to 9.1) |
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.
| Participants | Hereditary Hemorrhagic Telangiectasia (HHT) |
|---|---|
| Number of Participants That Achieving the Hemorrhage Adjusted Iron Requirement (HAIR) | 10 |
Chocolate can precipitate nosebleeds Food items intake assessed by 7-day weighed food diary
| Participants | Hereditary Hemorrhagic Telangiectasia (HHT) |
|---|---|
| Number of Participants That Ingested Chocolate | 14 |
Bread not precipitate nosebleeds Food items intake assessed by 7-day weighed food diary
| Participants | Hereditary Hemorrhagic Telangiectasia (HHT) |
|---|---|
| Number of Participants That Ingested Bread | 25 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Hereditary Hemorrhagic Telangiectasia (HHT) | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
| Age, Continuous(years) | Hereditary Hemorrhagic Telangiectasia (HHT) |
|---|---|
| Median | 55 (20 to 80) |
| Sex: Female, Male(Participants) | Hereditary Hemorrhagic Telangiectasia (HHT) |
|---|---|
| Female | 22 |
| Male | 28 |
| Race and Ethnicity Not Collected(Participants) | Hereditary Hemorrhagic Telangiectasia (HHT) |
|---|
| Region of Enrollment(participants) | Hereditary Hemorrhagic Telangiectasia (HHT) |
|---|---|
| United Kingdom | 50 |
Plan to share: No
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Imperial College London