Melatonin Replacement Therapy Effects on Cardiac Autonomic Activity in Pinealectomized Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- cardiac autonomic function - heart rate variability
研究概览
简要总结
This is an open-label, single-arm, single-center, proof-of-concept study to assess the effects of melatonin on cardiac autonomic activity in melatonin non-proficient pinealectomized patients.
详细描述
This is an open-label, single-arm, single-center, proof-of-concept study to assess the effects of melatonin on cardiac autonomic activity in melatonin non-proficient pinealectomized patients. The study consists of a screening period, followed by a 3-month melatonin treatment period, and a 6-month washout follow-up period. Adverse events were monitored with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 接受健康志愿者
- 否
入选标准
- •patients with pinealectomy and all of the following criteria were considered for admission to the clinical trial:
- •children, adolescents and young adults 0 months to 25 years of age;
- •signed written informed consent (patient or his/her parents/legal guardian);
- •willing and able to complete the clinical trial procedures, as described in the protocol
- •no recurring tumor after pinealectomy and subsequent chemotherapy
- •absence of circulating melatonin evaluated by salivary melatonin Elisa assay
排除标准
- •patients with cardiac arrhythmias
- •potentially non-compliant subjects judged by the investigator to be unsuitable for the study
研究组 & 干预措施
Melatonin Replacement Therapy
Melatonin (Aché Pharmaceutics, Brazil) 3 mg, administered in the evening, 30 minutes before the usual bedtime, every day for 3 months. After discontinuation of melatonin therapy, patients are followed up for 6 months to assess safety parameters and cardiac autonomic activity.
干预措施: Melatonin Replacement Therapy (Drug)
结局指标
主要结局
cardiac autonomic function - heart rate variability
时间窗: 9 months
The cardiac autonomic function was determined through heart rate variability (HRV) measures after polysomnography ECG recordings.
次要结局
未报告次要终点
研究者
Ovidiu Constantin Baltatu
Co-PI to PI - José Cipolla-Neto
Anhembi Morumbi University