University of Oxford OCMR & CCRF, John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU, United Kingdom
NCT Number: NCT02308449
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 exercise physiology are impaired by iron deficiency.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Oxford, Oxfordshire, OX3 9DU, United Kingdom
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 of whom will be iron-deficient. The study involves a screening visit and two half-day visits during which assessments are performed. 50% of each group will be randomised to receive iron-repletion with ferric carboxymaltose at the end of the first experimental visit before returning to repeat identical assessments around one week later. This approach will make it possible to explore whether baseline differences in skeletal muscle metabolism are explained by differences in iron status per se, whilst controlling for any learning effect during participation in the study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Infusion of 15 mg/kg (up to maximum 1000 mg) ferric carboxymaltose in 250 mL 0.9% sodium chloride
Other names: Ferinject
Infusion of 250 mL 0.9% sodium chloride
Other names: Normal saline
Time frame: 36 minute long graded exercise test; performed at baseline and follow-up visits (approximately a week apart)
Degree of phosphocreatine depletion during graded exercise of calf muscle assessed using magnetic resonance spectroscopy
Time frame: Hour long graded exercise test; performed at baseline and follow-up visits (approximately a week apart)
Blood lactate and cardiorespiratory parameters during moderate large skeletal muscle mass exercise, assessed with cardiopulmonary exercise testing
Time frame: Immediately before and immediately after hour long cardiopulmonary exercise test, performed at baseline and follow-up visits (approximately a week apart)
Skeletal muscle characteristics, assessed by minimally-invasive muscle biopsy (not a compulsory part of the protocol)
Time frame: At study screening visit compared to four weeks following infusion of iron or placebo
Measures of fatigue, restless-legs syndrome and well-being assessed by self-reported questionnaires
University of Oxford
Other
Effects of Endogenous Iron Status and Intravenous Iron on Human Skeletal Muscle Metabolism at Rest and During Exercise
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