Iron Deficiency and Hereditary Haemorrhagic Telangiectasia
Primary Purpose
Hereditary Haemorrhagic Telangiectasia
Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Ferrous sulphate 200mg oral tablet
Sponsored by
About this trial
This is an interventional treatment trial for Hereditary Haemorrhagic Telangiectasia focused on measuring Iron deficiency, Nosebleeds
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.
Sites / Locations
- Wellcome Trust-McMichael Clinical Research Facility, Imperial college London London, United Kingdom W12 0NN
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Iron treatment
Arm Description
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
Outcomes
Primary Outcome Measures
Blood iron indices
Secondary Outcome Measures
Full Information
NCT ID
NCT01908543
First Posted
July 23, 2013
Last Updated
September 25, 2023
Sponsor
Imperial College London
1. Study Identification
Unique Protocol Identification Number
NCT01908543
Brief Title
Iron Deficiency and Hereditary Haemorrhagic Telangiectasia
Official Title
Iron Deficiency and Hereditary Haemorrhagic Telangiectasia
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Technical issues with availability of relevant personnel
Study Start Date
July 2013 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Haemorrhagic Telangiectasia
Keywords
Iron deficiency, Nosebleeds
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Iron treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ferrous sulphate 200mg oral tablet
Other Intervention Name(s)
Iron tablet
Intervention Description
Administration by mouth
Primary Outcome Measure Information:
Title
Blood iron indices
Time Frame
4-5 hours after iron tablet ingestion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire L Shovlin, PhD FRCP
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wellcome Trust-McMichael Clinical Research Facility, Imperial college London London, United Kingdom W12 0NN
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Iron Deficiency and Hereditary Haemorrhagic Telangiectasia
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