The Fish and Fruit Study: Trial of Fish and Fruit to Improve Survival of Aboriginal People With End Stage Renal Disease
A Clinical Trial of Fish and Fruit to Improve Survival of Aboriginal People With End Stage Renal Disease
研究概览
详细说明
End stage renal disease (ESRD) is a devastating disease which affects Aboriginal Australians disproportionately: The average survival time for Aboriginal people in the Northern Territory is 3.6 years from the onset of kidney failure, compared to 12.3 years for non-Aboriginal people. There has been a dramatic rise in incidence of kidney failure over the past 20 years, with the prevalence doubling every 4-5 years in many NT communities and other remote parts of Australia. Mortality for patients with ESRD is approximately 5 to 10 fold that of the general population, with heart disease accounting for approximately half of deaths.
The aims of this study are to determine whether a dietary intervention of fish and fruit three times a week will decrease cardiovascular and all-cause mortality in patients on haemodialysis in Darwin and Alice Springs . There is a strong scientific rationale for this simple dietary intervention. Fish are a rich source of omega-3 fatty acids, believed to reduce the risk of heart attack. Fruit is a good source of anti oxidants and other chemicals that may amplify the beneficial effects of fish. Participants are randomized to either control and intervention groups according to their regular days of dialysis. Nutritional and cardiovascular status will be measured at commencement of the study and then at intervals of 3, 6 and 12 months.
Strategies have been incorporated into the project design to ensure understanding, informed consent and participation of Aboriginal people in a number of domains: the participant, their family, urban and remote communities, and service providers. If successful this intervention will result in changes to the clinical management of renal patients worldwide.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
-
-
Northern Territory
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Darwin、Northern Territory、澳大利亚、0810
- Department of Health and Community Services
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All patients on hemodialysis
Exclusion Criteria:
- Malignancy
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:case
diet of fish and fruit addition compared to regular diet
|
fish and fruit in specified quantities
其他名称:
Fish and fruit
|
|
安慰剂比较:control
regular diet
|
no drugs
no change in regular diet
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Deaths due to cardiovascular disease
大体时间:records continue to be checked till 2009
|
records continue to be checked till 2009
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Non-invasive cardiovascular markers: carotid intimal medial thickness
大体时间:completed 2008
|
completed 2008
|
合作者和调查者
调查人员
- 首席研究员:Kerin O'Dea, PhD、Menzies School of Health Research
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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