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Status unknownNCT03305705Updated Oct 13, 2017

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

A Phase 4 interventional study of Iron Carboxymaltose and Sodium chloride 0.9% in Fatigue and Iron-deficiency, sponsored by Albina Nowak, MD. Status unknown at 1 site in Switzerland. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-10-13.

Sponsored by Albina Nowak, MD · Phase 4, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Oct 2017), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Study 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
02

Conditions studied

  • Fatigue
  • Iron-deficiency
03

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
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

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
04

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • 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 · Drug: Sodium chloride 0.9%

  • 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 · Drug: Sodium chloride 0.9%

Interventions

  • DrugIron Carboxymaltose

    Single intravenous infusion within 20 min

    Also known as: Ferinject®

  • DrugSodium chloride 0.9%

    Single intravenous infusion of 250 ml within 20 min

    Also known as: NaCl 0.9 % (serves as Placebo)

05

What researchers measure

Primary outcomes

  1. Dopamine (DA) receptor density

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

    Time frame: 6 weeks

Secondary outcomes

  1. Fatigue

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

    Time frame: 6 weeks

  2. Fatigue

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

    Time frame: 6 weeks

  3. Neuropsychological symptoms

    Reduction of neuropsychological symptoms after iron supplementation determined by neuropsychological assessment

    Time frame: 6 weeks

06

Study locations

1 site
  • University Hospital Zurich
    Zürich, Switzerland
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03305705
Lead sponsor
Albina Nowak, MD
Responsible party
Albina Nowak, MD (senior physician, University of Zurich) — Sponsor-investigator
First posted
Oct 10, 2017
Start date
Oct 23, 2017 (estimated)
Primary completion
Aug 31, 2019 (estimated)
Completion
Aug 31, 2019 (estimated)
Last update
Oct 13, 2017

Study contacts

Albina Nowak, MD
Contact
albina.nowak@usz.ch
+41 (0)44 255 10 54
Albina Nowak, MD
principal investigator · University of Zurich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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