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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Zurich
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01374776
First received: June 15, 2011
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle) [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 24
Study Start Date: February 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374776

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

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01374776     History of Changes
Other Study ID Numbers: Version number 2 fro
Study First Received: June 15, 2011
Last Updated: December 12, 2013
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 26, 2014