Effect of Iron on Cerebral Dopamine Receptor Density in Non-anaemic Premenopausal Women With Low Ferritin and Fatigue
NCT ID: NCT03305705
Last Updated: 2017-10-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
20 participants
INTERVENTIONAL
2017-10-23
2019-08-31
Brief Summary
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* 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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
BASIC_SCIENCE
DOUBLE
Study Groups
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Treatment Arm 1
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.
Iron Carboxymaltose
Single intravenous infusion within 20 min
Sodium chloride 0.9%
Single intravenous infusion of 250 ml within 20 min
Treatment Arm 2
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.
Iron Carboxymaltose
Single intravenous infusion within 20 min
Sodium chloride 0.9%
Single intravenous infusion of 250 ml within 20 min
Interventions
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Iron Carboxymaltose
Single intravenous infusion within 20 min
Sodium chloride 0.9%
Single intravenous infusion of 250 ml within 20 min
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
18 Years
55 Years
FEMALE
No
Sponsors
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Albina Nowak, MD
OTHER
Responsible Party
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Albina Nowak, MD
senior physician
Principal Investigators
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Albina Nowak, MD
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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University Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Yulia Butscheid, PhD
Role: primary
Other Identifiers
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KEK-ZH-Nr. 2014-0217
Identifier Type: OTHER
Identifier Source: secondary_id
BASEC-Nr. PB_2017-00429
Identifier Type: -
Identifier Source: org_study_id