ClinicalTrials.gg
TerminatedNCT01908543Updated Sep 26, 2023

Iron Deficiency and Hereditary Haemorrhagic Telangiectasia

An interventional study of Ferrous sulphate 200mg oral tablet in Hereditary Haemorrhagic Telangiectasia, sponsored by Imperial College London. Terminated at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-09-26.

Sponsored by Imperial College London · Not applicable, Interventional, and Treatment

Why this study was terminated
Technical issues with availability of relevant personnel
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Hereditary Haemorrhagic Telangiectasia

Keywords

  • Iron deficiency
  • Nosebleeds
03

In context

Telangiectasia, Hereditary Hemorrhagic

106 studies on the registry are indexed under Telangiectasia, Hereditary Hemorrhagic; 24 are open to participants now.

This study's enrollment of 3 is below the median of 33 across 61 interventional studies indexed under Telangiectasia, Hereditary Hemorrhagic.

Browse Telangiectasia, Hereditary Hemorrhagic studies →

Lead sponsor

Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Inability to provide
  • Intercurrent infection or illness predicted to modify iron absorption.
  • Needle phobia.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • 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

Interventions

06

What researchers measure

Primary outcomes

  1. Blood iron indices

    Time frame: 4-5 hours after iron tablet ingestion

07

Study locations

1 site
  • Wellcome Trust-McMichael Clinical Research Facility, Imperial college London London, United Kingdom W12 0NN
    London, W12 0NN, United Kingdom
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2013 to primary completion in Jul 2015, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 23, 2013
First posted
Jul 25, 2013
StartActual
Jul 2013
Primary completionActual
Jul 2015
CompletionActual
Jul 2015
Last update
Sep 26, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 26, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01908543
Responsible party
Sponsor
First posted
Jul 25, 2013
Start date
Jul 2013
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Sep 26, 2023

Study contacts

Claire L Shovlin, PhD FRCP
principal investigator · Imperial College London

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ferrous sulfate

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