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

Primary Purpose

Fatigue, Iron-deficiency

Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Iron Carboxymaltose
Sodium chloride 0.9%
Sponsored by
Albina Nowak, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fatigue

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Zurich

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Arm 1

Treatment Arm 2

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Dopamine (DA) receptor density
Changes in the cerebral Dopamine (DA) receptor density determined by brain PET with the 11C-Raclopride tracer

Secondary Outcome Measures

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

Full Information

First Posted
September 19, 2017
Last Updated
October 12, 2017
Sponsor
Albina Nowak, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03305705
Brief Title
Effect of Iron on Cerebral Dopamine Receptor Density in Non-anaemic Premenopausal Women With Low Ferritin and Fatigue
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 23, 2017 (Anticipated)
Primary Completion Date
August 31, 2019 (Anticipated)
Study Completion Date
August 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Albina Nowak, MD

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Iron-deficiency

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment Arm 2
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Iron Carboxymaltose
Other Intervention Name(s)
Ferinject®
Intervention Description
Single intravenous infusion within 20 min
Intervention Type
Drug
Intervention Name(s)
Sodium chloride 0.9%
Other Intervention Name(s)
NaCl 0.9 % (serves as Placebo)
Intervention Description
Single intravenous infusion of 250 ml within 20 min
Primary Outcome Measure Information:
Title
Dopamine (DA) receptor density
Description
Changes in the cerebral Dopamine (DA) receptor density determined by brain PET with the 11C-Raclopride tracer
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Fatigue
Description
Reduction of fatigue after iron supplementation determined by Fatigue Assessment Scale (FAS)
Time Frame
6 weeks
Title
Fatigue
Description
Reduction of fatigue after iron supplementation determined by "Würzburger Erschöpfungs-Inventar bei Multipler Sklerose" (WEIMuS, in German) questionaire
Time Frame
6 weeks
Title
Neuropsychological symptoms
Description
Reduction of neuropsychological symptoms after iron supplementation determined by neuropsychological assessment
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albina Nowak, MD
Phone
+41 (0)44 255 10 54
Email
albina.nowak@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albina Nowak, MD
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zürich
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yulia Butscheid, PhD
Email
iron-dopamine@usz.ch
First Name & Middle Initial & Last Name & Degree
Yulia Butscheid, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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