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Muscle Status to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting

End Stage Renal Disease on Dialysis Clinical Trial

Official title:
Muscle Status to Oral Nutritional Supplementation in Hemodialysis Patients With Protein Energy Wasting

Clinical Trial Summary

This multi-centred randomized, open label-controlled trial consists of hemodialysis (HD) patients identified with protein energy wasting (PEW) using the International Society of Renal Nutrition and Metabolism criteria. Intervention provided was oral nutritional supplementation (ONS) for 6 months and changes in muscle status in response toward the treatment was measured using ultrasound imaging method pre- and post-intervention.

Clinical Trial Description

This study is a multi-centred randomized, open label-controlled trial where a total of 54 HD patients (29 intervention; 27 control) with PEW were recruited from government, private and non-governmental organization settings. Patients were randomized to either the intervention or control group. The intervention group received ONS (475 kcal and 21.7 g of protein), daily for 6 months. Both intervention and control group received standard nutritional counseling during the study period. Patients who consented were subjected to a screening for identification of PEW and other eligibility criteria. Patients who fulfilled the inclusion criteria were randomized to either control or intervention group. During the 6 months of treatment period, patients in both control and intervention groups were assessed at baseline, 3rd months and 6th months for changes in muscle status using ultrasound imaging and bio-impedance spectroscopy method, malnutrition inflammation complex syndrome using Malnutrition-Inflammation Score, and other measures indicative of nutritional status including anthropometry, biochemistry, dietary intake and quality of life assessment. These parameters were compared at baseline and 6 months for within and between group differences using general linear model test. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04789031
Study type Interventional
Source Taylor's University
Contact
Status Completed
Phase N/A
Start date June 1, 2016
Completion date July 31, 2019
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