Effect Of Intravenous Iron Versus Placebo On Muscle Oxidative Capacity And Physical Performance In Non Anemic Premenopausal Women With Low Ferritin Levels
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ClinicalTrials.gov Identifier: NCT01374776 |
Recruitment Status
: Unknown
Verified December 2013 by University of Zurich.
Recruitment status was: Recruiting
First Posted
: June 16, 2011
Last Update Posted
: December 13, 2013
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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
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 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 |

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Drug: Double blind, randomized, placebo controlled inter
- Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle) [ Time Frame: one year ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374776
Contact: 01 Studienregister MasterAdmins | +41 (0)44 255 11 11 |
Switzerland | |
University Hospital Zurich, Clinic and Policlinic of Internal Medicine | Recruiting |
Zurich, ZH, Switzerland, 8091 |
Principal Investigator: | Pierre-Alexandre Krayenbuehl, MD | University of Zurich |
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 Key Record Dates |
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 |