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

Albina Nowak, MD

Status and phase: Unknown; Phase 4

Conditions: Iron-deficiency; Fatigue

Treatments: Drug: Iron Carboxymaltose; Drug: Sodium chloride 0.9%

Study type: Interventional

Funder types: Other

Identifiers

NCT03305705

KEK-ZH-Nr. 2014-0217 (Other Identifier)

BASEC-Nr. PB_2017-00429

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Treatment Arm 1

Experimental group

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.

Treatment:

Drug: Sodium chloride 0.9%

Drug: Iron Carboxymaltose

Treatment Arm 2

Experimental group

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.

Treatment:

Drug: Sodium chloride 0.9%

Drug: Iron Carboxymaltose