Condition category
Haematological Disorders
Date applied
22/10/2009
Date assigned
18/05/2010
Last edited
04/02/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Annabel Nickol

ORCID ID

Contact details

Oxford Centre for Respiratory Medicine
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol version 3.0

Study information

Scientific title

A single blind, randomised controlled study of iron supplementation in iron deficient, but otherwise healthy, patients on hypoxic pulmonary vascular responses

Acronym

Study hypothesis

The purpose of this study is to test the hypothesis that patients with iron deficiency have extra large increases in pulmonary artery systolic pressure (PASP) when hypoxic, and that giving an iron infusion restores the normal response. We will therefore study patients with iron deficiency, but otherwise in good health, and iron-replete healthy volunteers. They will be randomised to receive an infusion of iron or a saline placebo, with PASP measured in acute hypoxia before, at intervals, and after the infusion. We will also see if other symptoms sometimes seen with iron deficiency (fatigue and restless legs), get better after the infusion.

Ethics approval

Mid and South Buckinghamshire Research Ethics Committee, 31/10/2009, ref: 08/H0607/66

Study design

Single-blind randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Iron deficiency

Intervention

1. Seeking consent, followed by a medical history and examination
2. Subjective symptom assessment
3. Blood test
4. Spirometry
5. Echocardiography
6. Acute hypoxic exposure with measurement of oxygen saturations, endtidal carbondioxide and breathing
7. Insertion of intravenous cannula
8. Infusion of saline (carried out if patient is randomised to the control limb)
9. Infusion of iron (carried out in all patients randomised to the test limb, and also at the end of the study offered to those who had been randomised to the control limb, as a therapeutic intervention)
10. Actigraphy (wearing small movement sensors like wrist watches around the ankles during sleep). Carried out in the participant's own home.

Study drug: Iron Carboxymaltose, up to 1000mg, once only.

Intervention type

Supplement

Phase

Not Specified

Drug names

Iron supplementation

Primary outcome measures

Acute hypoxic PASP post- compared to pre-iron infusion, measured at days 1, 2, 8 and 15.

Secondary outcome measures

Measured at weeks 1, 2, 4 and 8:
1. Time course of euoxic and hypoxic PASP post-iron infusion
2. Erythropoietin, and acute hypoxic cardiac output and ventilation post- compared to pre-iron infusion
3. Incidence of restless legs syndrome in iron deficient patients and iron replete healthy volunteers, and changes in symptoms and nocturnal leg movements following an iron infusion
4. Magnitude and time course of relief of fatigue post-iron infusion

Overall trial start date

09/11/2009

Overall trial end date

14/10/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Willing and able to give informed consent for participation in the study
2. Men and women aged 18 - 50 years and generally in good health
3. Detectable tricuspid regurgitation on echocardiography (enabling measurement of pulmonary arterial pressure)

For iron deficient patients:
4. Iron deficiency, defined as a ferritin less than 15 µg/L

For iron replete healthy volunteers:
5. Normal iron status (for example ferritin greater than 40 µg/L, iron 20 - 150 ng/ml, total iron binding capacity 250 - 450 ng/ml, and transferrin saturation 20 - 50%)

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

48

Participant exclusion criteria

1. Haemoglobin less than 7.0 g/dl
2. Haemoglobinopathy
3. Hypoxia at rest or on walking (saturation of oxygen in arterial blood [SaO2] less than 94%) or significant co-morbidity that may affect haematinics, pulmonary vascular or ventilatory responses, e.g. current infection, a chronic inflammatory condition, known cardio-valvular lesion or pulmonary hypertension, chronic airflow limitation
4. A cause for iron deficiency requiring urgent investigation, such as a bowel malignancy
5. Exposure to high altitude (greater than 2,500 m) within the previous six weeks, or air-travel greater than 4 hours within the previous week
6. Current or recent iron supplementation or blood transfusion within the previous 6 weeks
7. Pregnancy or breast feeding

Recruitment start date

09/11/2009

Recruitment end date

14/10/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford Centre for Respiratory Medicine
Oxford
OX3 7LJ
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
United Kingdom

Sponsor type

University/education

Website

http://www.admin.ox.ac.uk/rso/contactus/ctrg.shtml

Funders

Funder type

Industry

Funder name

Syner-Med (Pharmaceutical Products) Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The John Fell OUP Research Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Medical Research Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

04/02/2016: No publications found, verifying study status with principal investigator