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

Taylor's University

Status: Completed

Conditions: End Stage Renal Disease on Dialysis; Muscle Wasting

Treatments: Dietary Supplement: Oral nutritional supplementation (ONS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04789031

NKF/2018/SBS/01

NMRR-16-2525-32068 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• HD patients receiving standard dialysis treatment (3 sessions per week, 4 hours per session) for >3 months
• Aged between 18 to 70 years old
• Diagnosed with PEW using the ISRNM criteria

Exclusion criteria

• History of poor adherence to HD treatment
• Prolonged hospitalization or surgery in the past 3 months prior to recruitment
• Diagnosed with inflammatory diseases or malignancy
• Vegetarian
• Regular intake of ONS

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

54 participants in 2 patient groups

Intervention group

Experimental group

Description:

Patients received oral nutritional supplementation and standard nutritional counseling for 6 months.

Treatment:

Dietary Supplement: Oral nutritional supplementation (ONS)

Control group

No Intervention group

Description:

Patients received standard nutritional counseling for 6 months.