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

Study Overview
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Brief Summary
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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

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

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

Intervention / Treatment
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* Drug: intravenous iron carboxymaltose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous iron carboxymaltose<br>intravenous iron carboxymaltose infusion | Drug: intravenous iron carboxymaltose<br>* The patients will be randomized to one of the 2 treatment groups (12 patients in each group): Group I: intravenous iron carboxymaltose; Group II: intravenous placebo. Group I (intravenous iron): Ferinject will be applied via a short infusion. Patients will receive 15mg/kg of iron as iron carboxymaltose Ferinject® in 250 ml 0.9% NaCl intravenously (time of infusion 20 mins), in a single dose. The maximum dose is limited to 1000mg iron. Group II (intravenous placebo): Intravenous placebo (250 ml 0.9 % NaCl will be administrated in the same manner and time schedule than group I.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle) |  | one year |