Nutritional outcomes for a randomised investigation of nutritional supplements in patients who receive haemodialysis

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2013
INTERVENTION: Oral nutritional supplements versus standard care in haemodialysis patients An oral nutritional supplement will be provided to the intervention group each dialysis session for 2 months. A quality of life assessment, dietary interview and handgrip strength will be collected at baseline, 1 month and completion of the study (month 2) on both the intervention and control groups. The control group will continue to receive standard care but not the oral nutritional supplement. CONDITION: Haemodialysis ‐ a form of renal replacement therapy ; Urological and Genital Diseases PRIMARY OUTCOME: 1. Recruitment rate, refusal, withdrawal and dropout rate ; 2. Barriers to recruitment; 3. The ability to provide the intervention as per protocol; 4. Palatability and preference for types of oral nutritional supplements; 5. The feasibility, acceptability and appropriateness of data collection methods; 6. Data completion rates SECONDARY OUTCOME: The secondary outcomes relate to the efficacy of intradialytic nutritional supplementation on nutritional status. These parameters will help determine the most appropriate outcome measures and timing of data collection points for a larger RCT. Measures are:; 1. Handgrip dynamometry; 2. Quality of Life; 3. Weight; 4. Dietary intake INCLUSION CRITERIA: 1. Adult male or female haemodialysis patients 2. Received maintenance haemodialysis for at least 6 months 3. Receives haemodialysis at least 3 times per week 4. Has a body mass index of 22kg/m2 or less
Epistemonikos ID: 245b4e494d10df049592686a13cb119c407914fc
First added on: Aug 22, 2024