FatiguePhase 4NCT03305705
Effect of Iron on Cerebral Dopamine Receptor Density in Non-anaemic Premenopausal Women With Low Ferritin and Fatigue
A Phase 4 study testing Iron Carboxymaltose and Sodium chloride 0.9% in people with Fatigue and Iron-deficiency, run by Albina Nowak, MD at 1 site in Switzerland.
Trial summary
This study investigates the effect of intravenous iron substitution in non-anaemic premenopausal women with iron deficiency on: Changes in the cerebral Dopamine (DA) receptor density after iron substitution, shown by brain PET Reduction of fatigue and other neuropsychological symptoms after iron supplementation Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Fatigue, Iron-deficiency
- What is being tested?
- Iron Carboxymaltose and Sodium chloride 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 23 Oct 2017to 31 Aug 2019
- 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
- Women only
- 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 < 15 μg/ml, Hb > 120 g/L
- Adequate contraception during the study period
- Fatigue determined as 2 or more points in the basic questionnaire for fatigue
- Informed consent
Who cannot join
- Day-night shift work
- 11 or more points in the BDI
- No psychiatric disease (as assessed by neuropsychiatric assessment)
- 15 or more points in the ISI
- Known hypersensitivity to iron carboxymaltose, iron sucrose or iron sulfate
- Intake of iron preparations during the last 8 weeks before the start of the trial protocol
Show all 16Show fewer
- Pregnancy or lactation
- Any cardiovascular or pulmonary disease
- Acute or chronic infection/inflammation or malignancy
- Other obvious physical or psychiatric causes for fatigue (known mental disorders, e.g. depression)
- Chronic intake of concurrent medication (especially antipsychotic drugs), except oral contraceptives. Sporadic intake of NSAID or paracetamol, e.g. in the case of a common cold or sporadic headaches is allowed.
- CRP > 10 mg/L
- TSH out of normal range
- 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
- Known History of HIV/HBV/HCV
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich
Yulia Butscheid, PhD, iron-dopamine@usz.ch
Yulia Butscheid, PhD
About this study
Official title: Double-Blind, Single-Center Interventional Trial To Evaluate The Effect Of Intravenous Iron Versus Placebo On Cerebral Dopamine Receptor Density In Non Anaemic Premenopausal Women With Low Ferritin Levels And Fatigue
This study investigates the effect of intravenous iron substitution in non-anaemic premenopausal women with iron deficiency on:
- Changes in the cerebral Dopamine (DA) receptor density after iron substitution, shown by brain PET
- Reduction of fatigue and other neuropsychological symptoms after iron supplementation
- Conditions
- Fatigue, Iron-deficiency
- Being tested
- Iron Carboxymaltose, Sodium chloride 0.9%
- Medical subject headings
- Fatigue, Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron CarboxymaltoseDrug
Also called Ferinject®
Single intravenous infusion within 20 min
Sodium chloride 0.9%Drug
Also called NaCl 0.9 % (serves as Placebo)
Single intravenous infusion of 250 ml within 20 min
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1 | Experimental | Patients will be treated with 0.9% sodium chloride (placebo) at Visit 1 and with iron carboxymaltose in 6 weeks at Visit 2. The patients will be blinded with respect to the treatment sequence. Receives: Drug: Iron Carboxymaltose; Drug: Sodium chloride 0.9% |
| Treatment Arm 2 | Experimental | Patients will be treated with 0.9% sodium chloride (placebo) at Visit 1 and with iron carboxymaltose in 6 weeks at Visit 2. The patients will be blinded with respect to the treatment sequence. Receives: Drug: Iron Carboxymaltose; Drug: Sodium chloride 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dopamine (DA) receptor density
Changes in the cerebral Dopamine (DA) receptor density determined by brain PET with the 11C-Raclopride tracer
Measured: 6 weeks
Secondary outcomes (3)
Fatigue
Reduction of fatigue after iron supplementation determined by Fatigue Assessment Scale (FAS)
Measured: 6 weeks
Fatigue
Reduction of fatigue after iron supplementation determined by "Würzburger Erschöpfungs-Inventar bei Multipler Sklerose" (WEIMuS, in German) questionaire
Measured: 6 weeks
Neuropsychological symptoms
Reduction of neuropsychological symptoms after iron supplementation determined by neuropsychological assessment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start23 Oct 2017 (estimated)
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Aug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albina Nowak, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Albina Nowak, MD, University of Zurich
- Investigators
- Albina Nowak, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305705
- Sponsor's protocol ID
- BASEC-Nr. PB_2017-00429
- Other IDs
- KEK-ZH-Nr. 2014-0217
- Status last verified
- Oct 2017
- First submitted
- 19 Sep 2017
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Single-Center Interventional Trial To Evaluate The Effect Of Intravenous Iron Versus Placebo On Cerebral Dopamine Receptor Density In Non Anaemic Premenopausal Women With Low Ferritin Levels And Fatigue
- ClinicalTrials.gov ID
- NCT03305705
- Acronym / sponsor ID
- BASEC-Nr. PB_2017-00429
- Conditions
- Fatigue, Iron-deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Albina Nowak, MDUniversity, hospital or other
- Study start
- 23 Oct 2017 (estimated)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Aug 2019 (estimated)
- First posted
- 10 Oct 2017 (actual)
- 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.
This study investigates the effect of intravenous iron substitution in non-anaemic premenopausal women with iron deficiency on:
- Changes in the cerebral Dopamine (DA) receptor density after iron substitution, shown by brain PET
- Reduction of fatigue and other neuropsychological symptoms after iron supplementation
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1 | Experimental | Drug: Iron Carboxymaltose, Drug: Sodium chloride 0.9%Patients will be treated with 0.9% sodium chloride (placebo) at Visit 1 and with iron carboxymaltose in 6 weeks at Visit 2. The patients will be blinded with respect to the treatment sequence. |
| Treatment Arm 2 | Experimental | Drug: Iron Carboxymaltose, Drug: Sodium chloride 0.9%Patients will be treated with 0.9% sodium chloride (placebo) at Visit 1 and with iron carboxymaltose in 6 weeks at Visit 2. The patients will be blinded with respect to the treatment sequence. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- 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 < 15 μg/ml, Hb > 120 g/L
- Adequate contraception during the study period
- Fatigue determined as 2 or more points in the basic questionnaire for fatigue
Key exclusion criteria (16 listed)
- Day-night shift work
- 11 or more points in the BDI
- No psychiatric disease (as assessed by neuropsychiatric assessment)
- 15 or more points in the ISI
- Known hypersensitivity to iron carboxymaltose, iron sucrose or iron sulfate
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 |
|---|---|---|
| Iron CarboxymaltoseAlso: Ferinject®Single intravenous infusion within 20 min | Drug | Treatment Arm 1, Treatment Arm 2 |
| Sodium chloride 0.9%Also: NaCl 0.9 % (serves as Placebo)Single intravenous infusion of 250 ml within 20 min | Drug | Treatment Arm 1, Treatment Arm 2 |
Primary outcome
Dopamine (DA) receptor density
Time frame: 6 weeks
Changes in the cerebral Dopamine (DA) receptor density determined by brain PET with the 11C-Raclopride tracer
3 secondary outcomes
Fatigue
Time frame: 6 weeks
Fatigue
Time frame: 6 weeks
Neuropsychological symptoms
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Individual participant dataSharing planned: No
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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.
Albina Nowak, 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 Iron Carboxymaltose and Sodium chloride 0.9% in people with Fatigue and Iron-deficiency, run by Albina Nowak, MD 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 16 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: status not confirmed, as of the sponsor's last update on 13 Oct 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albina Nowak, MD (+41 (0)44 255 10 54, albina.nowak@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dopamine (DA) receptor density (time frame: 6 weeks). 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 13 Oct 2017.