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

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

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Key information

Conditions

Non Anemic Patients With Iron Deficiency (Low Ferritin Value)

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Zurich, Clinic and Policlinic of Internal Medicine

Zurich, Canton of Zurich, 8091, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intravenous iron carboxymaltose

Drug

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.

Primary outcomes

Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle)

Time frame: one year

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Jun 16, 2011
Registry last updated: May 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.