Iron supplementation in iron deficiency
| ISRCTN | ISRCTN01222004 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01222004 |
| Secondary identifying numbers | Protocol version 3.0 |
- Submission date
- 22/10/2009
- Registration date
- 18/05/2010
- Last edited
- 28/03/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Haematological Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Annabel Nickol
Scientific
Scientific
Oxford Centre for Respiratory Medicine
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom
Study information
| Study design | Single-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A single blind, randomised controlled study of iron supplementation in iron deficient, but otherwise healthy, patients on hypoxic pulmonary vascular responses |
| Study objectives | 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(s) | Mid and South Buckinghamshire Research Ethics Committee, 31/10/2009, ref: 08/H0607/66 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 09/11/2009 |
| Completion date | 14/10/2013 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 48 |
| Key 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%) |
| Key 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 |
| Date of first enrolment | 09/11/2009 |
| Date of final enrolment | 14/10/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oxford Centre for Respiratory Medicine
Oxford
OX3 7LJ
United Kingdom
OX3 7LJ
United Kingdom
Sponsor information
University of Oxford
University/education
University/education
Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
England
United Kingdom
| Website | http://www.admin.ox.ac.uk/rso/contactus/ctrg.shtml |
|---|---|
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Industry
Syner-Med (Pharmaceutical Products) Ltd (UK)
No information available
The John Fell OUP Research Fund (UK)
No information available
The Medical Research Fund (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 28/03/2018: Study not published due to 'a frustrating p=0.07, meaning results were not definitive, however it led on to further work with an amended protocol’ |
| IPD sharing plan |
Editorial Notes
28/03/2018: PI informed no publication intended, information added to publication and dissemination plan.
19/03/2018: No publications found, verifying study status with principal investigator.
04/02/2016: No publications found, verifying study status with principal investigator
