Calegari 2011.

Study characteristics
Methods	RCT. Duration: 2 phases (separated by a 1 month wash‐out). Phase 1: 3‐month intervention compared with control. Phase 2: Control group also received the intervention. Only data from Phase 1 included. Location: single centre study in Porto Alegre, Brazil.
Participants	Inclusion criteria: on haemodialysis. Exclusion criteria: clinically unstable, with infectious or inflammatory diseases, neoplasias, scheduled for transplant or death before inclusion in the study. Number randomised: 18 participants; intervention group n = 9, control group n = 9. Attrition: 15 (83%) completed the first phase. 2 participants died and 1 moved to peritoneal dialysis, all from control group. Gender split: 15 (83%) males, 3 (17%) females. Age: mean (SD) and range 56.4 (15.6) years, 26 years to 88 years. Nutritional status: BMI, mean (SD): intervention group 22.3 (2.3) kg/m², control group 20.9 (2.1) kg/m².
Interventions	Intervention: participants received dietary advice plus ONS in the form of oral nutritional supplementation (355 kcal, 53% carbohydrates, 10 g of proteins, 15 g of lipids, 257 mg of calcium, 271 mg of phosphorus, 313 mg of potassium, and 106 mg of sodium) during each haemodialysis session for 3 months; supplementation was offered to participants in the period between the beginning and mid‐dialysis. In addition, they were provided with special attention, such as nutritional guidance, family counselling, and dental assessment. Control: participants received no dietary advice and no ONS in the form of "routine nutritional guidance".
Outcomes	Nutritional status (dry weight, BMI, SGA); body composition (MAC, MAMA, lean mass, fat mass), QoL (SF‐36 domain scores); functional status (6‐minute walking test).
Publication details	Language: English. Funding: Instituto de Doenças Renais provided ingredients for the intervention formula. Publication status: peer‐reviewed journal.
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Not described.
Allocation concealment (selection bias)	Unclear risk	Not described.
Blinding (performance bias and detection bias) Clinical outcomes	Low risk	Not described but mortality unlikely to be influenced by lack of blinding.
Blinding (performance bias and detection bias) Functional outcomes	Unclear risk	Not described and likely to be influenced by lack of blinding.
Blinding (performance bias and detection bias) Nutritional outcomes	Unclear risk	Not described and likely to be influenced by lack of blinding.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Not blinded and likely that researchers and participants were aware of group allocation as this was a nutritional intervention. It is possible that assessment of some outcomes was influenced by lack of blinding
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	It is not stated whether the outcome assessors were blinded and some outcome assessment might be influenced by lack of blinding.
Incomplete outcome data (attrition bias) All outcomes	High risk	Attrition data fully reported, however, reasons were unbalanced between groups: 3/18 (17 %) in did not complete the first phase: intervention group 0/9 (0 %) and control group 3/9 (33 %); of these 2/9 (22 %) died and 1/9 (11 %) moved to peritoneal dialysis.
Selective reporting (reporting bias)	Unclear risk	No protocol identified. All outcomes mentioned in the methods are reported.
Other bias	Low risk	Intervention and control groups were similar at baseline.