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

NCT04789031 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-03-09

No results posted yet for this study

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.

Conditions

  • Muscle Wasting
  • End Stage Renal Disease on Dialysis

Interventions

DIETARY_SUPPLEMENT

Oral nutritional supplementation (ONS)

Patients received a renal specific ONS (Novasource Renal, Nestle) providing 475 kcal and 21.7g of protein per serving on a daily basis for 6 months. This was a ready-to- drink formula available in a tetrabrik pack. Patients consumed the product 30 minutes after commencing their dialysis session or at home after completion of dialysis.

Sponsors & Collaborators

  • National Kidney Foundation, United States

    collaborator OTHER

  • Taylor's University

    lead OTHER

Principal Investigators

  • Tilakavati Karupaiah, PhD · Taylor's University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2019-07-31
Completion
2019-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04789031 on ClinicalTrials.gov