NCT00597025已完成不适用
Impact of Providing High Protein Bar to Dialysis Patients With Low Serum Albumin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 4
- 主要终点
- The mean change (from baseline to month 3) in serum albumin levels among study groups and the proportion of patients treated with the protein food bar reaching an increase of 0.3 g/dL over the three month study period.
研究概览
简要总结
This study is to evaluate the impact of providing high protein supplementation in the form of a medical food bar containing 20grams of protein eath to hypoalbuminemic dialysis patients.
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
- •Subjects with ESRD undergoing center hemodialysis or peritoneal dialysis for more than 90 days.
- •18 years of age or older.
- •Must have a reasonable expectation of remaining on treatment for at least 3 months.
- •Must have an average serum albumin of <3.5 g/dL over the three months prior to entry into the study.
- •Must be able to understand and sign the informed consent.
- •Must be willing and able to participate in nutrition interviews for determination of nutrient intake from conventional foods.
排除标准
- •Allergy to protein, milk, nuts or wheat.
- •Documented ongoing acute infection or inflammatory process including treatment with antibiotics within a two week time of study entry.
- •Severe acidosis defined as pre-dialysis serum bicarbonate levels of <15 mEq/L.
- •Presence of conditions that would affect normal response to repletion of protein and calories, such as gastrointestinal disorders including inflammatory bowel disease.
- •Hospitalization for an infectious condition within 4 weeks prior to study entry.
- •Planned surgery within the three month study period including planned kidney transplantation.
结局指标
主要结局
The mean change (from baseline to month 3) in serum albumin levels among study groups and the proportion of patients treated with the protein food bar reaching an increase of 0.3 g/dL over the three month study period.
时间窗: Each month for the three months.
Incidence of potential adverse events including nausea, vomiting, diarrhea, acidosis, and uremic symptoms as evidenced by clinical symptoms and possible worsening of laboratory measures such as BUN, Kt/V, nPNA and bicarbonate.
时间窗: Each month for 3 months
次要结局
- Proportion of patients who reached the goal albumin of >3.5 g/dL during the study period(Month 3)
- Overall acceptance and compliance of bar form medical food over a 3 month period will be assessed via the proportion of patients who ingested 75% or more of the recommended bars.(Each month for 3 months)
- Impact of protein intake on laboratory measures such as pre-albumin, CRP and ferritin will be monitored(Each month for 3 months)
研究者
研究点 (4)
Loading locations...
相似试验
Unknown
不适用
Effect of Protein Intake During Hemodialysis on Blood Pressure and Arterial Stiffness IndicesEnd Stage Renal DiseaseHypotension During DialysisProtein MalnutritionArterial SclerosisNCT03947710Aristotle University Of Thessaloniki45
已完成
不适用
Effect of Protein Supplementation on Plasma Sodium Levels and Urinary Urea Excretion in Patients With SIADSyndrome of Inappropriate Antidiuresis (SIAD)NCT04987385University Hospital, Basel, Switzerland18
已完成
不适用
Whipple Protein StudyMalnutritionPancreatic CancerNCT04306874Thomas Jefferson University22
已完成
3 期
High-protein Oral Supplement With Liposomal Curcumin in Adults Undergoing Hemodialysis.Chronic Kidney Disease 5DNCT06381076University of Florida39
已完成
不适用
Protein Supplementation in Dialysis PatientsEnd Stage Renal DiseaseNCT01855295University of Utah73