Fatigue, Iron-deficiency
Conditions
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
Interventions
Single intravenous infusion within 20 min
DRUGSodium chloride 0.9%
Single intravenous infusion of 250 ml within 20 min
Sponsors
Albina Nowak, MD
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patients will be blinded with respect to the treatment sequence. The outcome assessor (PET scan evaluator) will be blinded with respect to the participant identity and the date of the PET scan.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dopamine (DA) receptor density | 6 weeks | Changes in the cerebral Dopamine (DA) receptor density determined by brain PET with the 11C-Raclopride tracer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue | 6 weeks | Reduction of fatigue after iron supplementation determined by Fatigue Assessment Scale (FAS) |
| Neuropsychological symptoms | 6 weeks | Reduction of neuropsychological symptoms after iron supplementation determined by neuropsychological assessment |
Countries
Switzerland
Contacts
Primary ContactAlbina Nowak, MD
Outcome results
None listed