Impact of Predialytic Oral Protein on Nutritional Status and Quality of Life in HD Patients

Alexandria University100 enrolled

Overview

The aim of this work is to study the effects of oral protein-based supplements on nutritional status in hemodialysis patients

Chronic kidney disease (CKD) is a prevalent chronic condition and the incidence of end-stage renal disease (ESRD) is expected to increase over the next few decades. In patients with CKD, especially in those with ESRD and undergoing maintenance dialysis therapy (MDT), a state of metabolic and nutritional derangements, more aptly called protein-energy wasting (PEW), caused by a combination of insufficient intake, uremic toxins, inflammation, and superimposed catabolism, plays a major role among the many risk factors that affect outcomes of CKD . Oral nutritional supplement (ONS) is a simple and effective way to supplement energy and protein to malnourished patients on the basis of regular diet. Therefore, if the protein of regular diet in dialysis patients are not enough, they should be supplemented with (ONS) when appropriate.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Hemodialysis Complication

Interventions

oral protein nutritional supplement (Fresubin protein powder)DIETARY_SUPPLEMENT

50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) 1 hour before the start of the session (predialytic) for 3 months

routine nutrition regimenOTHER

50 patients will receive a routine nutrition regimen for 3 months. (control group)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult hemodialysis patients (≥18 years of age). * Received dialysis for at least 6 months prior to study screening. * Receive hemodialysis at least 3 times per week . Exclusion Criteria: * Receiving nutritional supplementation prior to study commencing or within 1 month of commencement in the study . * Participants with an allergy to any ingredients in the nutritional supplements. * Persistent hyperkalemia or hyperphosphatemia (defined as the last 3 months). * Significant edema and fluid overload. * Hepatic patients

Locations (1)

Faculty of Medicine, Aexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

effect on nutritional status

assessment of nutritional status change at 3 months from baseline using Subjective Global Assessment (SGA)

Time frame: 3 months

effect on quality of life

assessment of quality of life change at 3 months from baseline using the kidney disease quality of life 36 (KDQOL-36) short form

Time frame: 3 months

Secondary Outcomes

effect on BMI

BMI assessment change at 3 months from baseline

Time frame: 3 months

mid arm circumference and triceps skin fold

Measurement of mid arm circumference and triceps skin fold change at 3 months from baseline

Time frame: 3 months

dialysis adequacy

Estimation of Kt/V change at 3 months from baseline

Time frame: 3 months

effect on serum albumin

measurement of serum albumin change at 3 months from baseline

Time frame: 3 months

Data from ClinicalTrials.gov

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