Protein Supplementation In Dialysis Patients
Condition: Peritoneal Dialysis Patients
Study type: Interventional

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).
    

Intervention name(s): Ceprolac; Dietary counseling (DC)
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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.; Received standard dietary counseling at baseline and month 6.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, open label controlled trial
Masking: None (Open Label)
Primary purpose: Treatment