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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich

Criteria

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