Hemodialysis Complication
Conditions
Keywords
oral protein, Protein Supplementation, Hemodialysis, quality of life
Brief summary
The aim of this work is to study the effects of oral protein-based supplements on nutritional status in hemodialysis patients
Detailed description
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.
Interventions
DIETARY_SUPPLEMENToral protein nutritional supplement (Fresubin protein powder)
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
OTHERroutine nutrition regimen
50 patients will receive a routine nutrition regimen for 3 months. (control group)
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This research is a randomized multi-center clinical trial in which 100 hemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1. * Group A: 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. * Group B: 50 patients will receive a routine nutrition regimen for 3 months. (control group)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| effect on nutritional status | 3 months | assessment of nutritional status change at 3 months from baseline using Subjective Global Assessment (SGA) |
| effect on quality of life | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| effect on BMI | 3 months | BMI assessment change at 3 months from baseline |
| mid arm circumference and triceps skin fold | 3 months | Measurement of mid arm circumference and triceps skin fold change at 3 months from baseline |
| dialysis adequacy | 3 months | Estimation of Kt/V change at 3 months from baseline |
| effect on serum albumin | 3 months | measurement of serum albumin change at 3 months from baseline |
Countries
Egypt
Outcome results
None listed