Status:
UNKNOWN
Effect of Iron on Cerebral Dopamine Receptor Density in Non-anaemic Premenopausal Women With Low Ferritin and Fatigue
Lead Sponsor:
Albina Nowak, MD
Conditions:
Fatigue
Iron-deficiency
Eligibility:
FEMALE
18-55 years
Phase:
PHASE4
Brief 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 sub...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
October 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03305705
Start Date
October 23 2017
End Date
August 31 2019
Last Update
October 13 2017
Active Locations (1)
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1
University Hospital Zurich
Zurich, Switzerland