Iron supplementation in iron deficiency

ISRCTN	ISRCTN01222004
DOI	https://doi.org/10.1186/ISRCTN01222004
Protocol serial number	Protocol version 3.0
Sponsor	University of Oxford
Funders	Syner-Med (Pharmaceutical Products) Ltd (UK), The John Fell OUP Research Fund (UK), The Medical Research Fund (UK)

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

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

Study information

Primary study design	Interventional
Study design	Single-blind randomised placebo-controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	Acute hypoxic PASP post- compared to pre-iron infusion, measured at days 1, 2, 8 and 15.
Key secondary outcome measure(s)	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
Completion date	14/10/2013

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Oxford Centre for Respiratory Medicine

Oxford
OX3 7LJ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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