CTRI/2020/12/030086尚未招募2/3 期
Safety and Efficacy of Oral Nutritional Supplement (RenoDiet-HP) in Patients with Chronic Kidney Disease Undergoing Maintenance Haemodialysis
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To assess any changes in the levels of serum albumin, haemoglobin, phosphorus, potassium, and total iron-binding capacity (TIBC), and body weight after treating with RenoDiet-HP for 03 months.
研究概览
简要总结
- Reno Diet-HP is specially designed high calorie and highprotein nutrition for the dietary management of CKD. It provides highbiological value (HBV) protein and meets the nutrition demands of dialysis byincreasing the body stores of protein and energy fuel, thus mitigating theeffects of PEW.
- The aim of the presentstudy is to explore the safety and efficacy oforal nutritional supplement (RenoDiet-HP) in patients with CKD undergoingmaintenance hemodialysis.
- The objective of the study is to assess any changes in the levels ofserum albumin, haemoglobin, phosphorus, potassium, and total iron-bindingcapacity (TIBC), and body weight after treating with RenoDiet-HP for 03 months and txo assess the Malnutrition InflammationScore (MIS) & Subjective Global Assessment (SGA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All consenting patients with CKD, above 18 years of age, and receiving twice or thrice weekly maintenance hemodialysis for atleast 6 months at the outpatient hemodialysis unit will be included in the study.
- •Patients willing to sign the Informed Consent Form (ICF).
排除标准
- •Patients with intercurrent acute illnesses.
- •Bodyweight less than 40 kg.
- •Documented history of dialysis non-compliance.
- •Documented malabsorption syndrome.
- •Contraindications to any ingredient of RenoDiet-HP.
- •Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
- •(Chronic illness may include but is not limited to, cardiac, renal, autoimmune, hepatic, haematological, genetic disorders, atopic conditions, congenital defects, diabetes, convulsions or encephalopathy, tuberculosis etc.).
- •Pregnant & Lactating women.
结局指标
主要结局
To assess any changes in the levels of serum albumin, haemoglobin, phosphorus, potassium, and total iron-binding capacity (TIBC), and body weight after treating with RenoDiet-HP for 03 months.
时间窗: 3 MONTHS
次要结局
- To assess the Malnutrition Inflammation Score (MIS) & Subjective Global Assessment (SGA).(3 MONTHS)
研究者
研究点 (1)
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