Clinical trial NCT01908543: Iron Deficiency and Hereditary Haemorrhagic Telangiectasia
Official title: Iron Deficiency and Hereditary Haemorrhagic Telangiectasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hereditary Haemorrhagic Telangiectasia
Keywords: Iron deficiency
Nosebleeds
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Blood iron indices
timeFrame: 4-5 hours after iron tablet ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Wellcome Trust-McMichael Clinical Research Facility, Imperial college London London, United Kingdom W12 0NN
Study officials:
affiliation: Imperial College London
name: Claire L Shovlin, PhD FRCP
role: PRINCIPAL_INVESTIGATOR
References: