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

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

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

Study Overview

• Status: Unknown
• Conditions: Fatigue; Iron-deficiency
• Intervention / Treatment: Drug: Iron Carboxymaltose; Drug: Sodium chloride 0.9%

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Zürich, Switzerland
    • University Hospital Zurich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment Arm 1; 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.	Drug: Iron Carboxymaltose; Single intravenous infusion within 20 min; Other Names: Ferinject®; Drug: Sodium chloride 0.9%; Single intravenous infusion of 250 ml within 20 min; Other Names: NaCl 0.9 % (serves as Placebo)
Experimental: Treatment Arm 2; 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.	Drug: Iron Carboxymaltose; Single intravenous infusion within 20 min; Other Names: Ferinject®; Drug: Sodium chloride 0.9%; Single intravenous infusion of 250 ml within 20 min; Other Names: NaCl 0.9 % (serves as Placebo)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dopamine (DA) receptor density	Changes in the cerebral Dopamine (DA) receptor density determined by brain PET with the 11C-Raclopride tracer	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue	Reduction of fatigue after iron supplementation determined by Fatigue Assessment Scale (FAS)	6 weeks
Fatigue	Reduction of fatigue after iron supplementation determined by "Würzburger Erschöpfungs-Inventar bei Multipler Sklerose" (WEIMuS, in German) questionaire	6 weeks
Neuropsychological symptoms	Reduction of neuropsychological symptoms after iron supplementation determined by neuropsychological assessment	6 weeks

Collaborators and Investigators

• Sponsor: Albina Nowak, MD
• Investigators: Principal Investigator: Albina Nowak, MD, University of Zurich

Study record dates

Study Major Dates

• Study Start (Anticipated): October 23, 2017
• Primary Completion (Anticipated): August 31, 2019
• Study Completion (Anticipated): August 31, 2019

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: October 9, 2017
• First Posted (Actual): October 10, 2017

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: October 12, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: BASEC-Nr. PB_2017-00429; KEK-ZH-Nr. 2014-0217 (Other Identifier: KEK Zurich)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No