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

Phase 4

Completed

• Conditions: Non Anemic Patients With Iron Deficiency (Low Ferritin Value)
• Interventions: Drug: intravenous iron carboxymaltose

• Registration Number: NCT01374776
• Lead Sponsor: University of Zurich

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-15
• Study First Submitted QC: 2011-06-15
• Study First Posted: 2011-06-16
• Study Start: 2013-02
• Primary Completion: 2014-09
• Study Completion: 2014-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intravenous iron carboxymaltose	intravenous iron carboxymaltose	intravenous iron carboxymaltose infusion

Primary Outcome Measures

Name	Time	Method
Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle)	one year

Trial Locations

Locations (1)

University Hospital Zurich, Clinic and Policlinic of Internal Medicine; 🇨🇭 Zurich, ZH, Switzerland