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
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Dopamine (DA) receptor density
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Iron Carboxymaltose (Drug)
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.
干预措施: Sodium chloride 0.9% (Drug)
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.
干预措施: Iron Carboxymaltose (Drug)
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.
干预措施: Sodium chloride 0.9% (Drug)
结局指标
主要结局
Dopamine (DA) receptor density
时间窗: 6 weeks
Changes in the cerebral Dopamine (DA) receptor density determined by brain PET with the 11C-Raclopride tracer
次要结局
- Neuropsychological symptoms(6 weeks)
- Fatigue(6 weeks)
研究者
Albina Nowak, MD
senior physician
University of Zurich