Oral Intradialytic Amino Acids Supplementation to Vitalize End-stage Kidney Disease Patients on Hemodialysis (OASIS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Brief Fatigue Inventory (BFI) score
研究概览
简要总结
The study will test and compare the efficacy of a single essential amino acid valine with a combination of essential amino acids (EAA) supplement on fatigue, frailty, and cognitive function in end-stage kidney disease (ESKD) patients undergoing hemodialysis (HD) treatment.
详细描述
This single center outpatient study will test and compare the efficacy of a single essential amino acid, valine with a combination of essential amino acids (EAA) supplementation on fatigue, fragility and cognitive function in end-stage kidney disease (ESKD) patients aged 18-64 years undergoing hemodialysis (HD) treatment at least three times a week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The intervention will be administered to the subjects by appropriately trained delegates.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •Age 18-64 years
- •Receiving 3 x weekly in clinic hemodialysis for at least 6 months
排除标准
- •Hypersensitivity to amino acid(s) and/or any excipient
- •Clinical documentation of COVID-19
- •Concomitant intake of amino acids supplements
- •Current use or abuse of alcohol, marijuana, narcotic, or other substances
- •Heart failure receiving active management
- •Malignant cancer receiving anticancer therapy
- •Diagnosis of major depressive disorder receiving antidepressants
- •Diagnosis of chronic liver disease
- •Cerebrovascular disease with sequelae
- •Upper limb amputation, osteoarthritis, or degenerative diseases of fingers, carpel tunnel syndrome in the non-fistula or graft hand preventing completion of hand grip strength test.
研究组 & 干预措施
Treatment group Valine then EEA
Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA
干预措施: EEA (Drug)
Treatment group EEA then Valine
EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine
干预措施: EEA (Drug)
Treatment group EEA then Valine
EAA will be administered as one 12.5 gm packet administered on dialysis treatment day followed by a washout and then Valine
干预措施: Valine (Drug)
Treatment group Valine then EEA
Valine will be administered as two 4 gm packets administered on dialysis treatment day followed by a washout period and then EEA
干预措施: Valine (Drug)
结局指标
主要结局
Brief Fatigue Inventory (BFI) score
时间窗: Baseline to 17 weeks
Changes in global fatigue score measured with the 9-item Brief Fatigue Inventory (BFI). The first 3 questions assess fatigue severity, and the remaining 6 questions measure the impact of fatigue on activity, mood, walking, work, relationships, and enjoyment of life. Respondents rate each item on a 0-10 numeric scale, with 0 meaning "no fatigue" and 10 meaning "fatigue as bad as you can imagine." Scores of all 9 items yield global fatigue burden. A lower average global fatigue score indicates milder fatigue and a higher score severe fatigue.
次要结局
- Trail Making Test (TMT)(Baseline to 17 weeks)
- Handgrip strength test(Baseline to 17 weeks)