NCT03305705

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2017

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 10, 2017

Completed
13 days until next milestone

Study Start

First participant enrolled

October 23, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

1.9 years

First QC Date

September 19, 2017

Last Update Submit

October 12, 2017

Conditions

FatigueIron-deficiency

Outcome Measures

Primary Outcomes (1)

  • Dopamine (DA) receptor density

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

    6 weeks

Secondary Outcomes (3)

  • Fatigue

    6 weeks

  • Fatigue

    6 weeks

  • Neuropsychological symptoms

    6 weeks

Study Arms (2)

Treatment Arm 1

EXPERIMENTAL

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 CarboxymaltoseDrug: Sodium chloride 0.9%

Treatment Arm 2

EXPERIMENTAL

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 CarboxymaltoseDrug: Sodium chloride 0.9%

Interventions

Iron CarboxymaltoseDRUG

Single intravenous infusion within 20 min

Also known as: Ferinject®
Treatment Arm 1Treatment Arm 2
Sodium chloride 0.9%DRUG

Single intravenous infusion of 250 ml within 20 min

Also known as: NaCl 0.9 % (serves as Placebo)
Treatment Arm 1Treatment Arm 2

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Day-night shift work
  • or more points in the BDI
  • No psychiatric disease (as assessed by neuropsychiatric assessment)
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

FatigueAnemia, Iron-Deficiency

Interventions

ferric carboxymaltoseSodium Chloride

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsAnemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Albina Nowak, MD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Albina Nowak, MD

CONTACT

+41 (0)44 255 10 54albina.nowak@usz.ch

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
senior physician

Study Record Dates

First Submitted

September 19, 2017

First Posted

October 10, 2017

Study Start

October 23, 2017

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

October 13, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)