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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet and nosebleed questionnaire | Experimental | Participants will only be required to fill in two paper questionnaires, one on dietary history, and one on nosebleed severity. |
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| Weighed food diary arm | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire on dietary history | Other |
| ||
| Questionnaire on nosebleed severity |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 1 year |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Ingested Chocolate | Chocolate can precipitate nosebleeds Food items intake assessed by 7-day weighed food diary | 3 months |
| Number of Participants That Ingested Bread | Bread not precipitate nosebleeds Food items intake assessed by 7-day weighed food diary |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire L Shovlin, PhD FRCP | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HHTIC London, Hammersmith Hospital, Imperial College Healthcare NHS Trust | London | W12 0NN | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24146883 | Result | Finnamore H, Le Couteur J, Hickson M, Busbridge M, Whelan K, Shovlin CL. Hemorrhage-adjusted iron requirements, hematinics and hepcidin define hereditary hemorrhagic telangiectasia as a model of hemorrhagic iron deficiency. PLoS One. 2013 Oct 16;8(10):e76516. doi: 10.1371/journal.pone.0076516. eCollection 2013. | |
| 24686867 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hereditary Hemorrhagic Telangiectasia (HHT) | Patients with hereditary hemorrhagic telangiectasia (HHT) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Other |
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| One week food diary generated by weighing foods | Other |
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| Blood tests for full blood count, albumin, and indices of nutritional status | Procedure |
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| 3 months |
| Finnamore HE, Whelan K, Hickson M, Shovlin CL. Top dietary iron sources in the UK. Br J Gen Pract. 2014 Apr;64(621):172-3. doi: 10.3399/bjgp14X677761. No abstract available. |
| 27195194 | Result | Chamali B, Finnamore H, Manning R, Laffan MA, Hickson M, Whelan K, Shovlin CL. Dietary supplement use and nosebleeds in hereditary haemorrhagic telangiectasia - an observational study. Intractable Rare Dis Res. 2016 May;5(2):109-13. doi: 10.5582/irdr.2016.01019. |
| 28347346 | Result | Finnamore H, Silva BM, Hickson BM, Whelan K, Shovlin CL. 7-day weighed food diaries suggest patients with hereditary hemorrhagic telangiectasia may spontaneously modify their diet to avoid nosebleed precipitants. Orphanet J Rare Dis. 2017 Mar 28;12(1):60. doi: 10.1186/s13023-017-0576-6. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Hereditary Hemorrhagic Telangiectasia (HHT) | Patients with hereditary hemorrhagic telangiectasia (HHT) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 1 year |
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| Primary | 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. | Posted | Median | Full Range | units | 3 months |
|
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| Primary | 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. | Posted | Count of Participants | Participants | 1 year |
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| Other Pre-specified | Number of Participants That Ingested Chocolate | Chocolate can precipitate nosebleeds Food items intake assessed by 7-day weighed food diary | 25 participants were filled up the 7-day weighed food diary | Posted | Count of Participants | Participants | 3 months |
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| |||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants That Ingested Bread | Bread not precipitate nosebleeds Food items intake assessed by 7-day weighed food diary | 25 participants were filled up the 7-day weighed food diary | Posted | Count of Participants | Participants | 3 months |
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hereditary Hemorrhagic Telangiectasia (HHT) | Patients with hereditary hemorrhagic telangiectasia (HHT) | 0 | 50 | 0 | 50 | 0 | 50 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| professor Claire Shovlin | Imperial College London | +44 (0)20 7589 5111 | c.shovlin@imperial.ac.uk |
| ID | Term |
|---|---|
| D013683 | Telangiectasia, Hereditary Hemorrhagic |
| D004844 | Epistaxis |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013684 | Telangiectasis |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| D001772 | Blood Cell Count |
| D000418 | Albumins |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D002468 | Cell Physiological Phenomena |
| D001790 | Blood Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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