Faculty of Medicine, Aexandria University
Alexandria, 21526, Egypt
NCT Number: NCT05952570
The aim of this work is to study the effects of oral protein-based supplements on nutritional status in hemodialysis patients
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Alexandria, 21526, Egypt
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
50 patients will receive a routine nutrition regimen for 3 months. (control group)
Time frame: 3 months
assessment of nutritional status change at 3 months from baseline using Subjective Global Assessment (SGA)
Time frame: 3 months
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
BMI assessment change at 3 months from baseline
Time frame: 3 months
Measurement of mid arm circumference and triceps skin fold change at 3 months from baseline
Time frame: 3 months
Estimation of Kt/V change at 3 months from baseline
Time frame: 3 months
measurement of serum albumin change at 3 months from baseline
Alexandria University
Other
The Impact of Predialytic Oral Protein-based Supplements on Nutritional Status and Quality of Life in Hemodialysis Patients
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