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. 2015 May 27;2015(5):CD001914. doi: 10.1002/14651858.CD001914.pub2

Bayram 2009.

Methods Randomized (2:1 randomization) controlled open‐label study.
Duration: 3 months (follow up of a subset of participants for a further 3 months).
Parallel design.
Single centre.
Location: Turkey.
No intention‐to‐treat analysis.
Participants 52 children (31 boys, 21 girls) with paediatric malignant disease receiving intensive chemotherapy.
Mean (SD) age 7.5 (3.0) years.
Treatment group n = 33: 18 children were diagnosed with leukaemia (12 acute lymphoblastic leukaemia, 6 acute myeloid leukaemia) and 15 had a solid tumour (4 non‐Hodgkin lymphoma, 3 neuroblastoma, 2 Wilm’s tumour, 2 brain tumour, 2 malignant bone tumour, 1 soft tissue tumour, and 1 hepatoblastoma).
Control group n = 19: 11 children were diagnosed with leukaemia (7 acute lymphoblastic leukaemia, 4 acute myeloid leukaemia) and 8 had a solid tumour (3 neuroblastoma, 2 soft tissue tumour, 1 brain tumour, 1 malignant bone tumour, and 1 retinoblastoma).
Interventions Treatment: usual dietary intake plus 2x daily (morning and evening) oral supplement (ProSure™) containing protein and energy dense EPA (banana and vanilla flavoured); each 240 ml container contained 300 kcal, 16 g protein, 1.09 g EPA (derived from deodorized sardine oil). Children supervised by a nurse specialized in nutrition who monitored compliance with supplement.
Control: usual dietary care.
Outcomes Body weight, BMI, weight percentiles, status of primary disease, attacks of febrile neutropenia and clinical status.
Measured monthly for 3 months. Subgroup of 23 children followed for further 3 months (6 months total).
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Children were randomized, using a 2:1 randomization scheme. No further details given.
Allocation concealment (selection bias) High risk Open‐label design and therefore did not maintain concealment of allocation.
Blinding (performance bias and detection bias) 
 All outcomes Low risk Not blinded. Outcomes were not affected by blinding due to the fact that they were objective measures.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There was no loss to follow up.
Selective reporting (reporting bias) Low risk Outcomes all reported in the Results as outlined in the Methods.