Effect Of Intravenous Iron Versus Placebo On Muscle Oxidative Capacity And Physical Performance in Premenopausal Women

Effect Of Intravenous Iron Versus Placebo On Muscle Oxidative Capacity And Physical Performance In Non Anemic Premenopausal Women With Low Ferritin Levels

Effect of intravenous iron substitution (iron carboxymaltose (Ferinject®), total dose 15 mg/ kg (maximal dose: 1000mg) in 250 ml 0.9 % NaCl; intravenous infusion in 20 min)in non-anemic premenopausal women with iron deficiency on

Primary objective:

- Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle)

Secondary objectives:

• Maximal oxygen uptake during a graded cycling exercise test and time to exhaustion at submaximal power during a constant-load cycling exercise test
• Plantarflexor muscle fatiguability as assessed by isokinetic dynamometry
• Trial with medicinal product

Inclusion criteria: INCLUSION CRITERIA

• Healthy female subjects, Age > 18 years, premenopausal, regularly menstruating
• BMI 18-25 kg/m2.
• Serum ferritin level < 15ug/ml
• Recreationally active with = 1.5 h/w structured activity
• Adequate contraception during the study period
• Informed consent

Exclusion criteria: EXCLUSION CRITERIA

• Anemia with Hb level < 120 g/l
• Known hypersensitivity to iron carboxymaltose, iron sucrose or iron sulfate
• Intake of iron preparations (also multivitamins containing iron) during the last 8 weeks before the start of the trial protocol
• Pregnancy or lactation
• Any cardiovascular or pulmonary disease
• Any orthopaedic or rheumatologic disease which affects exercise performance
• Presence of muscle disease
• Acute or chronic infection/inflammation or malignancy
• Known mental disorders (e.g. depression)
• Intake of concurrent medication, except oral contraceptives
• CRP > 10 mg/l
• TSH out of normal range
• Elevated CK (> 167 U/l)
• Any concurrent medical condition(s) that, in the view of the investigator, would prevent compliance or participation or jeopardize the health of the patients.
• Participation in any other therapeutic trial within the previous month