None listed
Conditions
Brief summary
Malnutrition is a significant and highly prevalent problem in those undergoing peritoneal dialysis (PD), and has been associated with increased morbidity and mortality. PD patients often experience gastrointestinal symptoms and together with a fluid restricted diet can limit the tolerance to nutritional supplements. The goal of this study is to evaluate the efficacy of provision of a nutritional supplement, given as a liquid (drink) or a food (snack bar) for improving the health outcomes of PD patients who are malnourished.
Interventions
Arm 1: oral nutritional supplement in a liquid form (i.e. a drink) providing 19g protein and 1.1 kJ of energy.
Arm 2: oral nutritional supplement in a solid form (i.e. a snack bar) providing 19g protein and 1.1 kJ of energy.
Each supplement will be consumed once per day (i.e one drink or one bar) for 8 weeks.
Sponsors
Southern Health - Monash Medical Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Peritoneal Dialysis patients who are malnourished or at risk of or malnourishment according to PG-SGA or who have serum albumin less than 35g/L.
Exclusion criteria
Under 18 years of age Patients on peritoneal dialysis for less than 3 months Patients with physical, cognitive, language or emotional problems which would prevent participation
Outcome results
None listed