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

Non Anemic Patients With Iron Deficiency (Low Ferritin Value) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374776
• Other study ID #: Version number 2 fro
• Status: Completed
• Phase: Phase 4
• Start date: February 2013
• Est. completion date: December 2014

Study information

• Verified date: May 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Non Anemic Patients With Iron Deficiency (Low Ferritin Value)

Intervention

Drug:
• intravenous iron carboxymaltose
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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Clinic and Policlinic of Internal Medicine	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle)		one year