Hereditary Haemorrhagic Telangiectasia (HHT)NCT01692015
Diet and Hereditary Haemorrhagic Telangiectasia
A study testing Questionnaire on dietary history, Questionnaire on nosebleed severity and One week food diary generated by weighing foods in people with Hereditary Haemorrhagic Telangiectasia (HHT), run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hereditary Haemorrhagic Telangiectasia (HHT)
- What is being tested?
- Questionnaire on dietary history, Questionnaire on nosebleed severity and One week food diary generated by weighing foods
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2011to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of hereditary Haemorrhagic Telangiectasia (HHT)
Who cannot join
- Unable to provide informed consent
- Presence of another major organ disorder that may affect nutritional status, such as inflammatory bowel disease, or celiac disease.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
HHTIC London, Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, W12 0NN
About this study
Official title: A Questionnaire Study on 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.
Read the detailed 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.
- Being tested
- 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
- Keywords
- Hereditary Haemorrhagic Telangiectasia, Nose bleeding, Iron supplements
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic, Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire on dietary historyOther
Questionnaire on nosebleed severityOther
One week food diary generated by weighing foodsOther
Blood tests for full blood count, albumin, and indices of nutritional statusProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Questionnaire on dietary history; Other: Questionnaire on nosebleed severity |
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startApr 2011
- Primary completionSep 2013
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hereditary Haemorrhagic Telangiectasia (HHT)Studies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire L Shovlin, PhD FRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692015
- Sponsor's protocol ID
- CLS21
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2012
- Last updated
- 29 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24146883Finnamore 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.
PubMed 24686867Chamali 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.
PubMed 27195194Finnamore 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.
PubMed 28347346
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Questionnaire Study on Diet and Hereditary Haemorrhagic Telangiectasia
- ClinicalTrials.gov ID
- NCT01692015
- Acronym / sponsor ID
- CLS21
- Keywords
- Hereditary Haemorrhagic Telangiectasia, Nose bleeding, Iron supplements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Apr 2011 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 25 Sep 2012 (estimated)
- Results
- Posted 29 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet and nosebleed questionnaire | Experimental | Other: Questionnaire on dietary history, Other: Questionnaire on nosebleed severityParticipants will only be required to fill in two paper questionnaires, one on dietary history, and one on nosebleed severity. |
| Weighed food diary arm | Experimental | 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 statusParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- A diagnosis of hereditary Haemorrhagic Telangiectasia (HHT)
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Presence of another major organ disorder that may affect nutritional status, such as inflammatory bowel disease, or celiac disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire on dietary history | Other | Diet and nosebleed questionnaire, Weighed food diary arm |
| Questionnaire on nosebleed severity | Other | Diet and nosebleed questionnaire, Weighed food diary arm |
| One week food diary generated by weighing foods | Other | Weighed food diary arm |
| Blood tests for full blood count, albumin, and indices of nutritional status | Procedure or surgery | Weighed food diary arm |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24146883Finnamore 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.
- Results publication: PubMed 24686867Finnamore 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.
- Results publication: PubMed 27195194Chamali 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.
- Results publication: PubMed 28347346Finnamore 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.
- Individual participant dataSharing planned: No
Related trials for Hereditary Haemorrhagic Telangiectasia (HHT)
RecruitingPhase 1/2
Harmony-HHT: ATV-1601 in Participants With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT), Osler Weber Rendu Disease
RecruitingObservational study
Quality of Life in Pediatric Participants With HHT
Hereditary Haemorrhagic Telangiectasia (HHT)
Not yet recruitingObservational study
Prevalence of Obstructive Sleep Apnea in HHT and HHT-specific Challenges in OSA-therapy - a Retrospective Cohort Study
Hereditary Hemorrhagic Telangiectasia (HHT), Obstructive Sleep Apnea (OSA)
Not yet recruitingPhase 1
Phase 1b Study of TX002100 in Participants With Hematologic Support-Dependent Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT)
Active, not recruitingPhase 1/2
A Study to Evaluate ALN-6400 in Healthy Volunteers and Patients With Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire L Shovlin, PhD FRCP principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire on dietary history, Questionnaire on nosebleed severity and One week food diary generated by weighing foods in people with Hereditary Haemorrhagic Telangiectasia (HHT), run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants That Achieving Personal Recommended Intake of Iron (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01692015, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024.