Clincosm LogoSign in Get a demo

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

Sponsor
Albina Nowak, MD (Other)
Overall Status
Unknown status
CT.gov ID
NCT03305705
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
22.2
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Iron Carboxymaltose
  • Drug: Sodium chloride 0.9%
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
Double (Participant, 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.
Primary Purpose:
Basic Science
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
Anticipated Study Start Date :
Oct 23, 2017
Anticipated Primary Completion Date :
Aug 31, 2019
Anticipated Study Completion Date :
Aug 31, 2019

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Dopamine (DA) receptor density [6 weeks]

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

    Secondary Outcome Measures

    1. Fatigue [6 weeks]

      Reduction of fatigue after iron supplementation determined by Fatigue Assessment Scale (FAS)

    2. Fatigue [6 weeks]

      Reduction of fatigue after iron supplementation determined by "Würzburger Erschöpfungs-Inventar bei Multipler Sklerose" (WEIMuS, in German) questionaire

    3. Neuropsychological symptoms [6 weeks]

      Reduction of neuropsychological symptoms after iron supplementation determined by neuropsychological assessment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Hospital Zurich Zürich Switzerland

    Sponsors and Collaborators

    • Albina Nowak, MD

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Albina Nowak, MD, senior physician, University of Zurich
    ClinicalTrials.gov Identifier:
    NCT03305705
    Other Study ID Numbers:
    • BASEC-Nr. PB_2017-00429
    • KEK-ZH-Nr. 2014-0217
    First Posted:
    Oct 10, 2017
    Last Update Posted:
    Oct 13, 2017
    Last Verified:
    Oct 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Fatigue

    Study Results

    No Results Posted as of Oct 13, 2017