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Iron Deficiency and Hereditary Haemorrhagic Telangiectasia

Sponsor
Imperial College London (Other)
Overall Status
Terminated
CT.gov ID
NCT01908543
Collaborator
(none)
3
Enrollment
1
Location
1
Arm
24
Actual Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ferrous sulphate 200mg oral tablet
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
3 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Iron Deficiency and Hereditary Haemorrhagic Telangiectasia
Actual Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Jul 1, 2015
Actual Study Completion Date :
Jul 1, 2015

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Blood iron indices [4-5 hours after iron tablet ingestion]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wellcome Trust-McMichael Clinical Research Facility, Imperial college London London, United Kingdom W12 0NN London United Kingdom W12 0NN

    Sponsors and Collaborators

    • Imperial College London

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Imperial College London
    ClinicalTrials.gov Identifier:
    NCT01908543
    Other Study ID Numbers:
    • CLS 2013/1
    First Posted:
    Jul 25, 2013
    Last Update Posted:
    Oct 9, 2019
    Last Verified:
    Oct 1, 2019
    Keywords provided by Imperial College London
    Iron deficiency
    Nosebleeds
    Additional relevant MeSH terms:
    Telangiectasis
    Telangiectasia, Hereditary Hemorrhagic
    Anemia, Iron-Deficiency

    Study Results

    No Results Posted as of Oct 9, 2019