Diet and Hereditary Haemorrhagic Telangiectasia

Hereditary Haemorrhagic Telangiectasia (HHT) Clinical Trial

Official title:

A Questionnaire Study on Diet and Hereditary Haemorrhagic Telangiectasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692015
• Other study ID #: CLS21
• Status: Completed
• Phase: N/A
• Start date: April 2011
• Est. completion date: September 2016

Study information

• Verified date: September 2023
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2016
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hereditary Haemorrhagic Telangiectasia (HHT)
• Telangiectasia, Hereditary Hemorrhagic
• Telangiectasis

Intervention

Other:
• Questionnaire on dietary history

• Questionnaire on nosebleed severity

• One week food diary generated by weighing foods

Procedure:
• Blood tests for full blood count, albumin, and indices of nutritional status

Locations

Country	Name	City	State
United Kingdom	HHTIC London, Hammersmith Hospital, Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

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 — View 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):e76 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants That Ingested Chocolate	Chocolate can precipitate nosebleeds Food items intake assessed by 7-day weighed food diary	3 months
Other	Number of Participants That Ingested Bread	Bread not precipitate nosebleeds Food items intake assessed by 7-day weighed food diary	3 months
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.	1 year
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.	3 months
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.	1 year