The Effect of Structured Medical Nutrition Therapy on Systemic Inflammation Index in Patients With Schizophrenia Receiving Antipsychotic Therapy
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Zsizsi Akbarinda
- 电话号码：+6281260993322
- 邮箱：zsizsiakbarinda12@gmail.com
学习地点
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Medan、印度尼西亚
- 招聘中
- Nutrition Department, Universitas Sumatera Utara, Medan, Indonesia
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
Adults aged 18-60 years. Diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
Receiving stable antipsychotic therapy for at least 4 weeks before enrollment. Hospitalized at Prof. Dr. M. Ildrem Psychiatric Hospital during the study period.
Able to consume an oral diet. Willing to participate and provide written informed consent (or consent provided by a legally authorized representative when applicable).
Exclusion Criteria:
Acute infection, autoimmune disease, malignancy, or other inflammatory conditions that may influence the Systemic Inflammation Index (SII).
Chronic liver disease, end-stage renal disease, or severe heart failure. Pregnancy or breastfeeding. Current use of systemic corticosteroids, immunosuppressive agents, or anti-inflammatory medications that could affect inflammatory biomarkers.
Receiving enteral or parenteral nutrition. Participation in another interventional clinical trial within the previous 3 months.
Incomplete clinical or laboratory data. Inability to complete the intervention or follow-up assessments.
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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假比较器：Hospitalized Diet
The control group received the standard hospital diet according to institutional nutritional care protocols.
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The control group received the standard hospital diet according to institutional nutritional care protocols.
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实验性的：Modification Diet
Diet modification was individualized to meet each patient's nutritional requirements and improve overall dietary quality.
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Diet modification was individualized to meet each patient's nutritional requirements and improve overall dietary quality.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Between-Group Difference in Change of Systemic Inflammation Index
大体时间：aseline and end of intervention (4-6 weeks)
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Systemic Inflammation Index (SII) will be calculated using the formula: platelet count × neutrophil count / lymphocyte count.
The primary endpoint is the difference in the change in SII from baseline to the end of the intervention between the structured Medical Nutrition Therapy group and the standard hospital diet group.
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aseline and end of intervention (4-6 weeks)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.