Effect of Iron on Cerebral Dopamine Receptor Density in Non-anaemic Premenopausal Women With Low Ferritin and Fatigue

• Status: Unknown status
• Trial end date: 2019-08-31
• Target enrollment: 0
• Participant gender: Female

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albina Nowak, MD
• Treatments: Dopamine; Ferric Compounds; Iron

Criteria

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