Iron Deficiency and Hereditary Haemorrhagic Telangiectasia

NCT01908543 | Terminated

• 1 other identifier: CLS 2013/1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Managing iron deficiency is important for more than 1 billion individuals worldwide, to avoid blood transfusions, or excessive strain on vital organs that depend on iron-containing haemoglobin to deliver oxygen to the tissues. Iron deficiency is a particular problem for people with the inherited condition hereditary haemorrhagic telangiectasia (HHT). Their iron deficiency and anaemia results from blood losses, especially from the nose (nosebleeds, and they often need additional iron to replace that lost through bleeding. Our goal is to stratify HHT patients into high/low absorbers of iron; to define what extra iron they need to adjust for their current and likely future blood losses; and to work out how to achieve this most safely for each individual to improve their later health. We will test the hypothesis that informed assessment of iron intake and post absorption cellular profiles changes the recommendations for iron intake for HHT patients.

Conditions

Hereditary Haemorrhagic Telangiectasia

Keywords

Iron deficiency; Nosebleeds

Outcome Measures

Primary Outcomes (1)

• Blood iron indices

  4-5 hours after iron tablet ingestion

Study Arms (1)

Iron treatment

EXPERIMENTAL

INTERVENTION: Ferrous sulphate 200mg oral tablet This is a single arm study. Individuals in this arm will * have an additional 15 mls of supplementary research bloods taken with their usual clinic bloods * receive a single tablet of ferrous sulphate 200mg * fill in questionnaires that formally evaluate their nosebleed losses and dietary iron intake in the preceding 12 months * have a second blood sample later that day (20 mls of blood Total number of participants in arm = 100

Drug: Ferrous sulphate 200mg oral tablet

Interventions

Ferrous sulphate 200mg oral tablet DRUG

Administration by mouth

Also known as: Iron tablet

Iron treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hereditary haemorrhagic telangiectasia (HHT). Definite diagnosis of HHT by international criteria.
• No iron tablets or treatment taken on day of assessment
• Ability to provide informed consent.

You may not qualify if:

• Inability to provide informed consent
• Intercurrent infection or illness predicted to modify iron absorption.
• Needle phobia.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Wellcome Trust-McMichael Clinical Research Facility, Imperial college London London, United Kingdom W12 0NN

London, W12 0NN, United Kingdom

Location

MeSH Terms

Conditions

Telangiectasia, Hereditary Hemorrhagic; Iron Deficiencies; Epistaxis

Interventions

ferrous sulfate; Tablets; Iron

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; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; 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)

Dosage Forms; Pharmaceutical Preparations; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Claire L Shovlin, PhD FRCP

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 25, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

GB (1)