Clinical Trial: Iron Deficiency and Hereditary Haemorrhagic Telangiectasia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Iron Deficiency and Hereditary Haemorrhagic Telangiectasia

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 Summary:

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

Sponsor: Imperial College London

Current Primary Outcome: Blood iron indices [ Time Frame: 4-5 hours after iron tablet ingestion ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Imperial College London

Dates:
Date Received: July 23, 2013
Date Started: July 2013
Date Completion: July 2017
Last Updated: May 28, 2015
Last Verified: July 2013