NCT02055534已完成不适用
Nutritional Counseling in Systemic Immunoglobulin Light-chain (AL) Amyloidosis: a Prospective Randomized, Controlled Trial.
Fondazione IRCCS Policlinico San Matteo di Pavia2 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2007年7月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Body weight
研究概览
简要总结
Poor nutritional status is common in patients with systemic immunoglobulin light-chain (AL) amyloidosis and has been associated with mortality and impaired quality of life (QoL). We investigated whether nutritional counseling is beneficial to the maintenance of nutritional status and QoL in AL outpatients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment naïve patients with with systemic immunoglobulin light-chain amyloidosis
- •Availability to planned measurements and to written informed consent
排除标准
- •Age < 18 years
- •Indication to organ transplantation
- •Indication to autologous stem cell transplantation
- •Need to start or ongoing dialysis
- •Ascites or massive edema
- •Need to start or ongoing artificial nutrition
结局指标
主要结局
Body weight
时间窗: 12 months
Change in body weight at 12 months
次要结局
- Quality of life(12 months)
- Overall survival(12 months)
研究者
Riccardo Caccialanza
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
研究点 (2)
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