Status:
COMPLETED
Iron Status and Human Metabolism
Lead Sponsor:
University of Oxford
Collaborating Sponsors:
British Heart Foundation
National Institute for Health Research, United Kingdom
Conditions:
Iron Deficiency
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Iron deficiency is common in cardiorespiratory diseases and appears to contribute to a worse outcome. This human physiology study will examine the extent to which human skeletal muscle metabolism and ...
Detailed Description
This is a prospective double-blind randomised controlled study of the effect of endogenous iron status on skeletal muscle metabolism and exercise physiology. 32 healthy volunteers will take part, half...
Eligibility Criteria
Inclusion
- Willing and able to give informed consent for participation in the study
- Men and women aged 18 years or older and generally in good health
- For iron-deficient volunteers: ferritin ≤ 15 microg/L and transferrin saturation \< 16%
- For iron-replete volunteers: ferritin ≥ 20 microg/L and transferrin saturation ≥ 20%
Exclusion
- Haemoglobin \< 8.0 g/dL
- Haemoglobinopathy
- Iron overload, defined as ferritin \> 300 microg/L
- Hypoxaemia (SpO2 \< 94%) or significant co-morbidity that may affect haematinics, metabolic or ventilatory responses
- Iron supplementation or blood transfusion within the previous 6 weeks
- Pregnancy or breast feeding
- Inability to exercise isolated calf muscle using a pedal or on a bicycle ergometer
- Contraindication to magnetic resonance spectroscopy exposure such as metallic implant
- Contraindication to receiving intravenous ferric carboxymaltose
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT02308449
Start Date
October 1 2014
End Date
January 1 2016
Last Update
July 19 2022
Active Locations (1)
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1
University of Oxford OCMR & CCRF, John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom, OX3 9DU