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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Non Anemic Patients With Iron Deficiency (Low Ferritin Value)	Drug: Double blind, randomized, placebo controlled inter	Phase 4

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	24 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Study Start Date :	February 2013
Estimated Primary Completion Date :	September 2014
Estimated Study Completion Date :	December 2014

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:

Drug: Double blind, randomized, placebo controlled inter
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.

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle) [ Time Frame: one year ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: 01 Studienregister MasterAdmins	+41 (0)44 255 11 11

Locations

Switzerland
University Hospital Zurich, Clinic and Policlinic of Internal Medicine	Recruiting
Zurich, ZH, Switzerland, 8091

Sponsors and Collaborators

University of Zurich

Investigators

Principal Investigator:	Pierre-Alexandre Krayenbuehl, MD	University of Zurich

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of Zurich
ClinicalTrials.gov Identifier:	NCT01374776 History of Changes
Other Study ID Numbers:	Version number 2 fro
First Posted:	June 16, 2011
Last Update Posted:	December 13, 2013
Last Verified:	December 2013

Additional relevant MeSH terms:

Anemia, Iron-Deficiency; Anemia, Hypochromic; Anemia	Hematologic Diseases; Iron Metabolism Disorders; Metabolic Diseases