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

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Non Anemic Patients With Iron Deficiency (Low Ferritin Value)

Treatments: Drug: intravenous iron carboxymaltose

Study type: Interventional

Funder types: Other

Identifiers

NCT01374776

Version number 2 fro

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 1 patient group

intravenous iron carboxymaltose

Experimental group

Description:

intravenous iron carboxymaltose infusion

Treatment:

Drug: intravenous iron carboxymaltose