Iron Deficiency and Hereditary Haemorrhagic Telangiectasia

NCT ID: NCT01908543

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2015-07-31

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.

Detailed Description

Relevant patients due to come to clinic or the programmed investigation unit will be offered the opportunity to participate in the study.

Up to 100 consenting individuals will

• have an additional 15 mls of supplementary research bloods taken
• 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)

The primary outcome measure is the change in serum iron levels post iron tablet.

Other outcome measures will include:

• Haematinic indices indicating whether their iron requirements have been met previously.
• Additional predicted iron intake requirements to adjust for haemorrhagic iron losses

Conditions

Hereditary Haemorrhagic Telangiectasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Iron treatment

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

Group Type: EXPERIMENTAL

Ferrous sulphate 200mg oral tablet

Intervention Type: DRUG

Administration by mouth

Interventions

Ferrous sulphate 200mg oral tablet

Administration by mouth

Intervention Type: DRUG

Other Intervention Names

Iron tablet

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claire L Shovlin, PhD FRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

CLS 2013/1

Identifier Type: -

Identifier Source: org_study_id