Effect of Iron on Cerebral Dopamine Receptor Density in Non-anaemic Premenopausal Women With Low Ferritin and Fatigue
Phase 4
- Conditions
- Iron-deficiencyFatigue
- Interventions
- Registration Number
- NCT03305705
- Lead Sponsor
- Albina Nowak, MD
- 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 substitution, shown by brain PET
* Reduction of fatigue and other neuropsychological symptoms after iron supplementation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 20
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Treatment Arm 2 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 1 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 1 Iron Carboxymaltose 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 Iron Carboxymaltose 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.
- Primary Outcome Measures
Name Time Method Dopamine (DA) receptor density 6 weeks Changes in the cerebral Dopamine (DA) receptor density determined by brain PET with the 11C-Raclopride tracer
- Secondary Outcome Measures
Name Time Method Neuropsychological symptoms 6 weeks Reduction of neuropsychological symptoms after iron supplementation determined by neuropsychological assessment
Fatigue 6 weeks Reduction of fatigue after iron supplementation determined by "Würzburger Erschöpfungs-Inventar bei Multipler Sklerose" (WEIMuS, in German) questionaire
Trial Locations
- Locations (1)
University Hospital Zurich
🇨🇭Zürich, Switzerland