Skip to content

Iron supplementation in iron deficiency

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN01222004
Enrollment
48
Registered
2010-05-18
Start date
2009-11-09
Completion date
Unknown
Last updated
2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron deficiency Haematological Disorders Iron deficiency anaemia

Interventions

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

Sponsors

University of Oxford
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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%)

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026