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Protein Supplementation In Dialysis Patients

Exploring The Therapeutic Benefits Of Oral Protein Supplementation In Malnourished Dialysis Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03367000
Enrollment
74
Registered
2017-12-08
Start date
2012-02-01
Completion date
2013-08-31
Last updated
2017-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peritoneal Dialysis Patients

Brief summary

The dialysis population has a strikingly high incidence of mortality. The life expectancy of chronic dialysis patients is 20 years less than that of the general population. Approximately 50% of individuals with end stage renal disease (ESRD) die from a cardiovascular (CV) cause with mortality being 15 to 30 times higher than the age-adjusted CV mortality in the general population. There is also a steady increase of patients with diabetes and the older age groups coming into dialysis. The treatment of patients with ESRD aims at prolonging life, achieving good nutritional status and promoting the best possible functioning and quality of life (QOL). Several factors that are beyond adequacy of dialysis predict high mortality in ESRD patients. Associated co-morbidities and malnutrition factors are independently associated and the combined presence of both malnutrition and co-morbidities manifest the worst survival.Therefore this study investigates the efficacy of protein supplementation in improving health status and quality of life among peritoneal dialysis (PD) patients. This research will also generate basic data about significant health markers critical to the health status of PD patients.

Detailed description

This study is a randomised, open labeled controlled trial where a total of 74 PD patients (37 supplemented; 37 control) were recruited from government and private settings. Subjects were randomised to either the intervention or control group. The intervention group received hydrolysed whey protein supplement and diet counselling for 6 months while the control group received only diet counselling for 6 months. Patients who consented were first subjected to a screening for identification of eligible subjects. The screening involved basic anthropometry measures (height, weight, BMI), routine biochemistry result obtained from medical record, assessment of nutritional status and dietary evaluation. About 4ml of pre-dialysis blood was also collected by respective nurses for additional laboratory parameters (hsCRP). During the 6 months of treatment period, patients in both control and intervention groups were assessed at baseline and end of the study (at 6 months) for anthropometry assessment, laboratory results, medical condition, hospitalisations, nutritional status, dietary intake and compliance towards supplementation (intervention group only).

Interventions

DIETARY_SUPPLEMENTCeprolac

The supplement was packed into two \ 15g sachets in powder form of a 90-94% whey protein isolate and hydrolysed whey. The protein powder was dissolved in 75-100ml water at room temperature and was ingested post meal once daily.

OTHERDietary counseling (DC)

Received standard dietary counseling at baseline and month 6.

Sponsors

National University of Malaysia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized, open label controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Aged \> 18 years old and ≤70 years old * Undergone dialysis at least for 6 months. * Categorised as malnourished based on BMI \<24 kg/m² and serum albumin ≤40 g/L criteria * No incidence of hospitalisation for past 3 months, free of infection/sepsis and have not undergone surgery for past 6 months.

Exclusion criteria

* Patients with high inflammatory diseases, malignancy, cancer * Vegetarian patients

Design outcomes

Primary

MeasureTime frameDescription
Serum albuminChange from baseline serum albumin at 6 months of the studyBiochemistry marker that indicates nutritional status
Body mass index (BMI)Change from BMI at 6 months of the studyIndex that depicts if one's current weight is ideal for their height

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026