Iron Deficiency and Hereditary Haemorrhagic Telangiectasia

September 25, 2023 updated by: Imperial College London

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Ferrous sulphate 200mg oral tablet
Administration by mouth
Other Names:
  • Iron tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood iron indices
Time Frame: 4-5 hours after iron tablet ingestion
4-5 hours after iron tablet ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Investigators

  • Principal Investigator: Claire L Shovlin, PhD FRCP, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (Estimated)

July 25, 2013

Study Record Updates

Last Update Posted (Actual)

September 26, 2023

Last Update Submitted That Met QC Criteria

September 25, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLS 2013/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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