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

A

Alexandria University

Status

Enrolling

Conditions

Hemodialysis Complication

Treatments

Dietary Supplement: oral protein nutritional supplement (Fresubin protein powder)
Other: routine nutrition regimen

Study type

Interventional

Funder types

Other

Identifiers

NCT05952570
oral protein in HD

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups, including a placebo group

protein supplement
Experimental group
Description:
50 patients will receive oral protein nutritional supplement (Fresubin protein powder 25mg/5scoops per hemodialysis session) for 3 months
Treatment:
Dietary Supplement: oral protein nutritional supplement (Fresubin protein powder)
control
Placebo Comparator group
Description:
50 patients will receive a routine nutrition regimen for 3 months. (control group)
Treatment:
Other: routine nutrition regimen

Trial contacts and locations

0

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Central trial contact

Mohamed Mamdouh Elsayed, MD

Data sourced from clinicaltrials.gov

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