Sharma 2002b.

Study characteristics
Methods	RCT. Parallel group with 3 arms. Duration: 1 month. Location: single centre in India.
Participants	Inclusion criteria: adults with renal disease receiving maintenance dialysis x3 weekly for more than 1 month, BMI < 20 kg/m2, and serum albumin < 4.0 g/dL. Exclusion criteria: diabetes, presence of intercurrent illness. Number randomised: 47 participants (intervention group 1, n = 10; intervention group 2, n = 16; control group, n = 14 control). Attrition: 40 participants analysed; 7 dropouts (intervention groups n = 5; control group n = 2). Gender split: 35 males, 5 females. Age: mean intervention group 1 (commercial supplement) 29.6 years; intervention group 2 (home blend) 32.7 years; control group 31.9 years. Nutritional status: mean (SD) BMI, intervention 1, 17.9 (1.3) kg/m2; intervention 2, 17.2 (1.9) kg/m2 control 17.1 (1.9) kg/m2. Nutritional status: all participants had a BMI < 20 kg/m² and serum albumin < 4.0 g/dL.
Interventions	Intervention (group 1): participants received dietary advice and ONS in the form of dietary counselling to increase intake in line with current recommendations for renal disease plus 300 mL of commercial supplement (500 kcal, 15 g protein). Intervention (group 2): participants received dietary advice and ONS in the form of dietary counselling to increase intake in line with current recommendations for renal disease plus 300 mL of home‐produced blend providing similar kcal and protein. Control: participants received dietary advice alone in the form of dietary counselling to increase intake but in line with current recommendations for renal disease.
Outcomes	Weight*, biochemistry, energy intake*, protein intake*, appetite, Karnofski index, supplementation acceptability questionnaire.
Publication details	Language: English. Funding: the study was supported by Baxter and by a hospital fund. Publication status: peer‐reviewed journal.
Notes	This study is a duplicate of Sharma 2002a. The study has 2 intervention arms and a single control group. Therefore the number of participants in the control group is divided by 2. This study ID describes the data of intervention group 'commercial supplement' versus control, whereas Sharma 2000a describes 'home blend' versus control. Study is eligible for inclusion on the basis of the intervention; however, due to the high number of control participants that crossed over to the intervention, data cannot be included without further analysis. Participants were randomised 1:2 into control and intervention, and in turn the experimental group was randomised to receive the commercial nutritional supplement or home‐prepared supplement blend.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No details given.
Allocation concealment (selection bias)	Unclear risk	No details given.
Blinding (performance bias and detection bias) Clinical outcomes	Low risk	Is is unlike that biochemistry measured were influenced by knowing the group allocation.
Blinding (performance bias and detection bias) Functional outcomes	High risk	The trial was unblinded. Functional outcomes could have been influenced by lack of blinding.
Blinding (performance bias and detection bias) Nutritional outcomes	High risk	The trial was unblinded. Nutritional outcomes could have been 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	Judged to be unclear because low risk for clinical outcomes and high risk for functional and nutritional outcomes.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	7 dropouts; 5 of 26 (19%) in the intervention group and 2 of 14 (14%) in the control group. Reasons not given.
Selective reporting (reporting bias)	High risk	No study protocol identified, thus unable to judge whether all planned outcomes were reported. Data not all in usable format and not available from author, therefore mean change (SD) has been derived by calculation from the data in Table 2.
Other bias	High risk	Baseline data only presented on participants that completed the study (n = 40). 5 participants crossed over from the control to the supplement group.