A single-arm, prospective study to evaluate the effects of oral nutritional supplementation in chronic kidney disease (CKD) patients on maintenance hemodialysis (MHD)
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- To evaluate the effect of oral nutraceutical supplementation on the protein levels (change in serum albumin concentration) in patients with CKD on maintenance dialysis.
研究概览
简要总结
This study is an single-arm, Single center, prospective study to evaluate the effect of oral nutraceutical supplementation on the protein levels when given twice daily for 3 months in 78 patients (≥ 18 years) with Chronic kidney disease (CKD) on maintenance hemodialysis (MHD) that will be conducted in India. The primary endpoint will be change in serum albumin concentration and the secondary endpoint will be change in 24-hour dietary recall in patients over the study period (3 months) in patients with CKD on maintenance dialysis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age ≥ 18 years 2) Subjects on maintenance hemodialysis diagnosed as malnourished (serum albumin concentration <4 g/dL and/or a loss of ≥ 5% dry weight [DW] over the past 3 months) 3)Body weight history of past 6 months 4)Subjects willing to participate in the study 5)Subjects willing to consume the nutritional drink as per the protocol.
排除标准
- •Patients with recurrent acute illnesses 2)Body weight less than 40 kg 3)Documented history of dialysis noncompliance 4)Documented malabsorption syndromes 5)Chronic inflammatory diseases of unknown origin 6)Recent surgery within 3 months or during follow-up 7)Contraindications to any of the ingredients of the nutritional supplement 8)Major cardiovascular event, or death during follow-up; 9)Patients with nephrotic syndrome; 10)Patients with history of malignancy 11)Chronic liver disease 12)Pregnant and lactating women.
- •Patient taking any other nutritional supplement.
结局指标
主要结局
To evaluate the effect of oral nutraceutical supplementation on the protein levels (change in serum albumin concentration) in patients with CKD on maintenance dialysis.
时间窗: Screening/Basline (Visit 1), Month 1 Follow up(Visit 2), Month 2 Follow up (Visit 3) Month 3 End of study (Visit 4)
次要结局
- To assess the nutritional status using 24-hour dietary recall, modified subjective global assessment from baseline to 3 months.(1. To assess the risk of malnutrition using hand grip strength from baseline to 3 months.)