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. 2011 Sep 7;2011(9):CD002008. doi: 10.1002/14651858.CD002008.pub4

de Luis 2003.

Methods Randomised controlled trial. 
 Duration 3 months.
Participants Adults (n = 70, dietary advice + supplement group 71.4% men, mean age (SD) 37.5 years (11), dietary advice group 82.8 % men, mean age (SD) 39.9 years (9 years)) with HIV infection and 5% or more weight loss in previous 6 months.
Interventions Dietary advice to increase energy and protein intake and 3 x 250 ml supplement (Ensure) (n = 33) versus dietary advice to increase energy and protein intake (n = 33).
Outcomes Survival*, weight*, BMI*, TSF*, MUAC*, energy intake*, immune function, cardiac function.
Notes Additional data and information on quality obtained from authors.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Information from the author indicated that a random number series was used to generate a sequence.
Allocation concealment (selection bias) Low risk Information from the author indicated that sealed envelopes were used to conceal allocation.
Blinding (performance bias and detection bias) 
 Clinical outcomes High risk Information from the author indicated that outcome assessment was not blinded.
Blinding (performance bias and detection bias) 
 Functional outcomes High risk Information from the author indicated that outcome assessment was not blinded.
Blinding (performance bias and detection bias) 
 Nutritional outcomes High risk Information from the author indicated that outcome assessment was not blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 6 participants withdrew between randomisation and baseline:
Intervention group: 4 deaths, 1 loss to follow‐up;
Control group: 1 loss to follow‐up.
Selective reporting (reporting bias) Low risk All specified outcomes reported but not all in a format usable for meta‐analysis. Change in weight, TSF, MAMC and energy intake are reported as mean (SD) at baseline and end of intervention. Mean change (SD) obtained from authors.
Other bias Low risk Baseline variables stated, groups similar at baseline.