Iron Deficiency and Hereditary Haemorrhagic Telangiectasia
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|ClinicalTrials.gov Identifier: NCT01908543|
Recruitment Status : Unknown
Verified July 2013 by Imperial College London.
Recruitment status was: Recruiting
First Posted : July 25, 2013
Last Update Posted : May 29, 2015
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|
|Hereditary Haemorrhagic Telangiectasia||Drug: Ferrous sulphate 200mg oral tablet||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Iron Deficiency and Hereditary Haemorrhagic Telangiectasia|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||July 2017|
U.S. FDA Resources
Experimental: Iron treatment
INTERVENTION: Ferrous sulphate 200mg oral tablet
This is a single arm study. Individuals in this arm will
Total number of participants in arm = 100
Drug: Ferrous sulphate 200mg oral tablet
Administration by mouth
Other Name: Iron tablet
- Blood iron indices [ Time Frame: 4-5 hours after iron tablet ingestion ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908543
|Wellcome Trust-McMichael Clinical Research Facility, Imperial college London London, United Kingdom W12 0NN||Recruiting|
|London, United Kingdom, W12 0NN|
|Contact: Claire L Shovlin, PhD FRCP email@example.com|
|Principal Investigator: Claire L Shovlin, PhD FRCP|
|Principal Investigator:||Claire L Shovlin, PhD FRCP||Imperial College London|