Non Anemic Patients With Iron Deficiency (Low Ferritin Value)Phase 4NCT01374776
Effect Of Intravenous Iron Versus Placebo On Muscle Oxidative Capacity And Physical Performance in Premenopausal Women
A Phase 4 study testing intravenous iron carboxymaltose in people with Non Anemic Patients With Iron Deficiency (Low Ferritin Value), run by University of Zurich at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Non Anemic Patients With Iron Deficiency (Low Ferritin Value)
- What is being tested?
- intravenous iron carboxymaltose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2013to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Clinic and Policlinic of Internal Medicine
Zurich, Canton of Zurich, 8091
About this study
Official title: Effect Of Intravenous Iron Versus Placebo On Muscle Oxidative Capacity And Physical Performance In Non Anemic Premenopausal Women With Low Ferritin Levels
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
- Being tested
- intravenous iron carboxymaltose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous iron carboxymaltoseDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| intravenous iron carboxymaltose | Experimental | intravenous iron carboxymaltose infusion Receives: Drug: intravenous iron carboxymaltose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study startFeb 2013
- Primary completionSep 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Anemic Patients With Iron Deficiency (Low Ferritin Value)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Alexandre Krayenbuehl, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374776
- Sponsor's protocol ID
- Version number 2 fro
- Status last verified
- May 2021
- First submitted
- 15 Jun 2011
- Last updated
- 7 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Intravenous Iron Versus Placebo On Muscle Oxidative Capacity And Physical Performance In Non Anemic Premenopausal Women With Low Ferritin Levels
- ClinicalTrials.gov ID
- NCT01374776
- Acronym / sponsor ID
- Version number 2 fro
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intravenous iron carboxymaltose | Experimental | Drug: intravenous iron carboxymaltoseintravenous iron carboxymaltose infusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intravenous iron carboxymaltoseThe 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. | Drug | intravenous iron carboxymaltose |
Primary outcome
Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle)
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Alexandre Krayenbuehl, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing intravenous iron carboxymaltose in people with Non Anemic Patients With Iron Deficiency (Low Ferritin Value), run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitochondrial capacity (Phosphocreatine Recovery rate assessed by 31P-MR-spectroscopy of the lower leg muscle) (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.