Clinical trial NCT01692015: Diet and Hereditary Haemorrhagic Telangiectasia
Official title: A Questionnaire Study on Diet and Hereditary Haemorrhagic Telangiectasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hereditary Haemorrhagic Telangiectasia (HHT)
Keywords: Hereditary Haemorrhagic Telangiectasia
Nose bleeding
Iron supplements
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2012-09-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants That Achieving Personal Recommended Intake of Iron
timeFrame: 1 year
measure: Nosebleed Severity
timeFrame: 3 months
measure: Number of Participants That Achieving the Hemorrhage Adjusted Iron Requirement (HAIR)
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Number of Participants That Ingested Chocolate
timeFrame: 3 months
measure: Number of Participants That Ingested Bread
timeFrame: 3 months
Locations:
city: London
country: United Kingdom
facility: HHTIC London, Hammersmith Hospital, Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Claire L Shovlin, PhD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.