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

Fatigue Clinical Trial

Official title:

Double-Blind, Single-Center Interventional Trial To Evaluate The Effect Of Intravenous Iron Versus Placebo On Cerebral Dopamine Receptor Density In Non Anaemic Premenopausal Women With Low Ferritin Levels And Fatigue

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03305705
• Other study ID #: BASEC-Nr. PB_2017-00429
• Secondary ID: KEK-ZH-Nr. 2014-
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 19, 2017
• Last updated: October 12, 2017
• Start date: October 23, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: October 2017
• Source: University of Zurich
• Contact: Albina Nowak, MD
• Phone: +41 (0)44 255 10 54
• Email: albina.nowak[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Fatigue
• Iron-deficiency

Intervention

Drug:
• Iron Carboxymaltose
Single intravenous infusion within 20 min
• Sodium chloride 0.9%
Single intravenous infusion of 250 ml within 20 min

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Albina Nowak, MD

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dopamine (DA) receptor density	Changes in the cerebral Dopamine (DA) receptor density determined by brain PET with the 11C-Raclopride tracer	6 weeks
Secondary	Fatigue	Reduction of fatigue after iron supplementation determined by Fatigue Assessment Scale (FAS)	6 weeks
Secondary	Fatigue	Reduction of fatigue after iron supplementation determined by "Würzburger Erschöpfungs-Inventar bei Multipler Sklerose" (WEIMuS, in German) questionaire	6 weeks
Secondary	Neuropsychological symptoms	Reduction of neuropsychological symptoms after iron supplementation determined by neuropsychological assessment	6 weeks