Hereditary Haemorrhagic TelangiectasiaNCT01908543
Iron Deficiency and Hereditary Haemorrhagic Telangiectasia
A study testing Ferrous sulphate 200mg oral tablet in people with Hereditary Haemorrhagic Telangiectasia, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hereditary Haemorrhagic Telangiectasia
- What is being tested?
- Ferrous sulphate 200mg oral tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to provide informed consent
- Intercurrent infection or illness predicted to modify iron absorption.
- Needle phobia.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wellcome Trust-McMichael Clinical Research Facility, Imperial college London London, United Kingdom W12 0NN
London, W12 0NN
About this study
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
- Conditions
- Hereditary Haemorrhagic Telangiectasia
- Being tested
- Ferrous sulphate 200mg oral tablet
- Keywords
- Iron deficiency, Nosebleeds
- Medical subject headings
- Telangiectasia, Hereditary Hemorrhagic, Iron Deficiencies, Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulphate 200mg oral tabletDrug
Also called Iron tablet
Administration by mouth
| Study group | Role | What they receive |
|---|---|---|
| Iron treatment | Experimental | 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 Receives: Drug: Ferrous sulphate 200mg oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood iron indices
Measured: 4-5 hours after iron tablet ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Technical issues with availability of relevant personnel
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary Haemorrhagic TelangiectasiaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire L Shovlin, PhD FRCP, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908543
- Sponsor's protocol ID
- CLS 2013/1
- Status last verified
- Sep 2023
- First submitted
- 23 Jul 2013
- Last updated
- 26 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iron Deficiency and Hereditary Haemorrhagic Telangiectasia
- ClinicalTrials.gov ID
- NCT01908543
- Acronym / sponsor ID
- CLS 2013/1
- Conditions
- Hereditary Haemorrhagic Telangiectasia
- Keywords
- Iron deficiency, Nosebleeds
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical issues with availability of relevant personnel
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Jul 2013 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iron treatment | Experimental | Drug: Ferrous sulphate 200mg oral tabletINTERVENTION: 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Intercurrent infection or illness predicted to modify iron absorption.
- Needle phobia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous sulphate 200mg oral tabletAlso: Iron tabletAdministration by mouth | Drug | Iron treatment |
Primary outcome
Blood iron indices
Time frame: 4-5 hours after iron tablet ingestion
Results and safety
The study was stopped early (reason given: Technical issues with availability of relevant personnel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire L Shovlin, PhD FRCP principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous sulphate 200mg oral tablet in people with Hereditary Haemorrhagic Telangiectasia, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Technical issues with availability of relevant personnel). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood iron indices (time frame: 4-5 hours after iron tablet ingestion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.