Diet and Hereditary Haemorrhagic Telangiectasia

NCT01692015 | Completed Results

• 1 other identifier: CLS21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hereditary Haemorrhagic Telangiectasia (HHT)

Keywords

Hereditary Haemorrhagic Telangiectasia; Nose bleeding; Iron supplements

Outcome Measures

Primary Outcomes (3)

• 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

Other Outcomes (2)

• Number of Participants That Ingested Chocolate

  3 months

• Number of Participants That Ingested Bread

  3 months

Study Arms (2)

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.

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.

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

Interventions

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

Weighed food diary arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of hereditary Haemorrhagic Telangiectasia (HHT)

You may not qualify if:

• Unable to provide informed consent
• Presence of another major organ disorder that may affect nutritional status, such as inflammatory bowel disease, or celiac disease.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

HHTIC London, Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, W12 0NN, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 24146883 RESULT

• 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.

  PMID: 24686867 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.

  PMID: 27195194 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.

  PMID: 28347346 RESULT

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic; Epistaxis

Interventions

Hematologic Tests; Blood Cell Count; Albumins

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Telangiectasis; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cell Count; Cytological Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: professor Claire Shovlin
• Organization: Imperial College London

c.shovlin@imperial.ac.uk

+44 (0)20 7589 5111

Study Officials

• Claire L Shovlin, PhD FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 25, 2012
• Study Start: April 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2016
• Last Updated: March 29, 2024
• Results First Posted: March 29, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)