Iron deficiency Haematological Disorders Iron deficiency anaemia
Conditions
Interventions
Sponsors
Eligibility
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
| Measure | Time frame |
|---|---|
| Acute hypoxic PASP post- compared to pre-iron infusion, measured at days 1, 2, 8 and 15. | — |
Secondary
| Measure | Time 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