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. |
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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). |
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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. |
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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). |
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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. |