<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03305705</url>
  </required_header>
  <id_info>
    <org_study_id>BASEC-Nr. PB_2017-00429</org_study_id>
    <secondary_id>KEK-ZH-Nr. 2014-0217</secondary_id>
    <nct_id>NCT03305705</nct_id>
  </id_info>
  <brief_title>Effect of Iron on Cerebral Dopamine Receptor Density in Non-anaemic Premenopausal Women With Low Ferritin and Fatigue</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Albina Nowak, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigates the effect of intravenous iron substitution in non-anaemic&#xD;
      premenopausal women with iron deficiency on:&#xD;
&#xD;
        -  Changes in the cerebral Dopamine (DA) receptor density after iron substitution, shown by&#xD;
           brain PET&#xD;
&#xD;
        -  Reduction of fatigue and other neuropsychological symptoms after iron supplementation&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 23, 2017</start_date>
  <completion_date type="Anticipated">August 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2019</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Dopamine (DA) receptor density</measure>
    <time_frame>6 weeks</time_frame>
    <description>Changes in the cerebral Dopamine (DA) receptor density determined by brain PET with the 11C-Raclopride tracer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>6 weeks</time_frame>
    <description>Reduction of fatigue after iron supplementation determined by Fatigue Assessment Scale (FAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue</measure>
    <time_frame>6 weeks</time_frame>
    <description>Reduction of fatigue after iron supplementation determined by &quot;Würzburger Erschöpfungs-Inventar bei Multipler Sklerose&quot; (WEIMuS, in German) questionaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neuropsychological symptoms</measure>
    <time_frame>6 weeks</time_frame>
    <description>Reduction of neuropsychological symptoms after iron supplementation determined by neuropsychological assessment</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Fatigue</condition>
  <condition>Iron-deficiency</condition>
  <arm_group>
    <arm_group_label>Treatment Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment Arm 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Iron Carboxymaltose</intervention_name>
    <description>Single intravenous infusion within 20 min</description>
    <arm_group_label>Treatment Arm 1</arm_group_label>
    <arm_group_label>Treatment Arm 2</arm_group_label>
    <other_name>Ferinject®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium chloride 0.9%</intervention_name>
    <description>Single intravenous infusion of 250 ml within 20 min</description>
    <arm_group_label>Treatment Arm 1</arm_group_label>
    <arm_group_label>Treatment Arm 2</arm_group_label>
    <other_name>NaCl 0.9 % (serves as Placebo)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy female subjects, Age &gt; 18 years, premenopausal, regularly menstruating&#xD;
&#xD;
          -  BMI 18-25 kg/m2&#xD;
&#xD;
          -  Serum ferritin level &lt; 15 μg/ml, Hb &gt; 120 g/L&#xD;
&#xD;
          -  Adequate contraception during the study period&#xD;
&#xD;
          -  Fatigue determined as 2 or more points in the basic questionnaire for fatigue&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Day-night shift work&#xD;
&#xD;
          -  11 or more points in the BDI&#xD;
&#xD;
          -  No psychiatric disease (as assessed by neuropsychiatric assessment)&#xD;
&#xD;
          -  15 or more points in the ISI&#xD;
&#xD;
          -  Known hypersensitivity to iron carboxymaltose, iron sucrose or iron sulfate&#xD;
&#xD;
          -  Intake of iron preparations during the last 8 weeks before the start of the trial&#xD;
             protocol&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Any cardiovascular or pulmonary disease&#xD;
&#xD;
          -  Acute or chronic infection/inflammation or malignancy&#xD;
&#xD;
          -  Other obvious physical or psychiatric causes for fatigue (known mental disorders, e.g.&#xD;
             depression)&#xD;
&#xD;
          -  Chronic intake of concurrent medication (especially antipsychotic drugs), except oral&#xD;
             contraceptives. Sporadic intake of NSAID or paracetamol, e.g. in the case of a common&#xD;
             cold or sporadic headaches is allowed.&#xD;
&#xD;
          -  CRP &gt; 10 mg/L&#xD;
&#xD;
          -  TSH out of normal range&#xD;
&#xD;
          -  Any concurrent medical condition(s) that, in the view of the investigator, would&#xD;
             prevent compliance or participation or jeopardize the health of the patients.&#xD;
&#xD;
          -  Participation in any other therapeutic trial within the previous month&#xD;
&#xD;
          -  Known History of HIV/HBV/HCV&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Albina Nowak, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Albina Nowak, MD</last_name>
    <phone>+41 (0)44 255 10 54</phone>
    <email>albina.nowak@usz.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital Zurich</name>
      <address>
        <city>Zürich</city>
        <country>Switzerland</country>
      </address>
    </facility>
    <contact>
      <last_name>Yulia Butscheid, PhD</last_name>
      <email>iron-dopamine@usz.ch</email>
    </contact>
    <investigator>
      <last_name>Yulia Butscheid, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <last_update_submitted>October 12, 2017</last_update_submitted>
  <last_update_submitted_qc>October 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Zurich</investigator_affiliation>
    <investigator_full_name>Albina Nowak, MD</investigator_full_name>
    <investigator_title>senior physician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Iron Deficiencies</mesh_term>
    <mesh_term>Fatigue</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03305705
org study id: BASEC-Nr. PB_2017-00429
secondary id: KEK-ZH-Nr. 2014-0217
nct id: NCT03305705
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Basic Science
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.
measure: Dopamine (DA) receptor density
time frame: 6 weeks
description: Changes in the cerebral Dopamine (DA) receptor density determined by brain PET with the 11C-Raclopride tracer
measure: Fatigue
time frame: 6 weeks
description: Reduction of fatigue after iron supplementation determined by Fatigue Assessment Scale (FAS)
measure: Fatigue
time frame: 6 weeks
description: Reduction of fatigue after iron supplementation determined by "Würzburger Erschöpfungs-Inventar bei Multipler Sklerose" (WEIMuS, in German) questionaire
measure: Neuropsychological symptoms
time frame: 6 weeks
description: Reduction of neuropsychological symptoms after iron supplementation determined by neuropsychological assessment
arm group label: Treatment Arm 1
arm group type: Experimental
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 group label: Treatment Arm 2
arm group type: Experimental
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: Iron Carboxymaltose
description: Single intravenous infusion within 20 min
arm group label: Treatment Arm 1
arm group label: Treatment Arm 2
other name: Ferinject®
intervention type: Drug
intervention name: Sodium chloride 0.9%
description: Single intravenous infusion of 250 ml within 20 min
arm group label: Treatment Arm 1
arm group label: Treatment Arm 2
other name: NaCl 0.9 % (serves as Placebo)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Albina Nowak, MD
role: Principal Investigator
affiliation: University of Zurich
last name: Albina Nowak, MD
phone: +41 (0)44 255 10 54
email: albina.nowak@usz.ch
facility: 
contact: 
investigator: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: University of Zurich
investigator full name: Albina Nowak, MD
investigator title: senior physician
mesh term: Iron Deficiencies
mesh term: Fatigue
sharing ipd: No