Iron Deficiency and Hereditary Haemorrhagic Telangiectasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Imperial College London
Sponsor:
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01908543
First received: July 23, 2013
Last updated: NA
Last verified: July 2013
History: No changes posted
  Purpose

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 Intervention
Hereditary Haemorrhagic Telangiectasia
Drug: Ferrous sulphate 200mg oral tablet

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Iron Deficiency and Hereditary Haemorrhagic Telangiectasia

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Blood iron indices [ Time Frame: 4-5 hours after iron tablet ingestion ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Administration by mouth
Other Name: Iron tablet

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01908543

Locations
United Kingdom
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       c.shovlin@imperial.ac.uk   
Principal Investigator: Claire L Shovlin, PhD FRCP         
Sponsors and Collaborators
Imperial College London
Investigators
Principal Investigator: Claire L Shovlin, PhD FRCP Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01908543     History of Changes
Other Study ID Numbers: CLS 2013/1
Study First Received: July 23, 2013
Last Updated: July 23, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Imperial College London:
Iron deficiency
Nosebleeds

Additional relevant MeSH terms:
Telangiectasia, Hereditary Hemorrhagic
Telangiectasis
Anemia, Iron-Deficiency
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities
Anemia, Hypochromic
Anemia
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014