Prevention of Depression With Omega-3 Fatty Acids in Chronic Carriers of Hepatitis C Treated With Interferon Alpha.
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The effect of omega three fatty acids would be estimated through two questionnaires which filled by the patients monthly
研究概览
简要总结
The purpose of the study is to check whether development of depression as a side effect of interferon alpha treatment in chronic carriers of hepatitis C can be prevented by omega-3 fatty acids.
详细描述
Omega-3 fatty acids are known as an alternative treatment for different conditions, including mental conditions, such as depression. We assume that combining omega-3 with the treatment by interferon alpha may prevent the development of depression, which is quite a common side effect of the interferon alpha.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic carriers of hepatitis C who start a course of interferon alpha treatment, and are treated in the liver clinic of Bnai Zion hospital.
排除标准
- •Disagreement to participation in trial.
- •Diagnosed and active mental illness.
- •Encephalopathic patients.
- •Patients with limited ability to understand the questionnaires or the informed consent process.
结局指标
主要结局
The effect of omega three fatty acids would be estimated through two questionnaires which filled by the patients monthly
with the BDI questionnaire which estimates the level of depression of the patient and
the SF36 questionnaire which provides information about the overall influence of a disease upon a patient's daily life and mental status.
次要结局
- Secondary outcome measures include monthly results of biochemical and hematologic blood tests, including levels of:
- albumin
- bilirubin
- ALT
- CRP
- hemoglobin
- WBC
- platelets