Clinical trial NCT03367000: Protein Supplementation In Dialysis Patients
Official title: Exploring The Therapeutic Benefits Of Oral Protein Supplementation In Malnourished Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peritoneal Dialysis Patients
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open label controlled trial
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Serum albumin
timeFrame: Change from baseline serum albumin at 6 months of the study
measure: Body mass index (BMI)
timeFrame: Change from BMI at 6 months of the study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Senior Lecturer
name: Tilakavati Karupaiah
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
citation: Sahathevan S, Se CH, Ng S, Khor BH, Chinna K, Goh BL, Gafor HA, Bavanandan S, Ahmad G, Karupaiah T. Clinical efficacy and feasibility of whey protein isolates supplementation in malnourished peritoneal dialysis patients: A multicenter, parallel, open-label randomized controlled trial. Clin Nutr ESPEN. 2018 Jun;25:68-77. doi: 10.1016/j.clnesp.2018.04.002.