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. 2017 May 4;2017(5):CD000406. doi: 10.1002/14651858.CD000406.pub5

Kalnins 2005.

Study characteristics
Methods Quasi‐randomised controlled trial.
Parallel design.
Duration: 3 months.
Location: single centre in Canada.
Participants CF participants aged > 10 years. Age on entry to trial: advice group mean (SD) 16.4 years (6.7); supplement group mean (SD) 19.5 years (11.3).
< 90% ideal WFH or 5% reduction in ideal WFH over 3 months.
Most recent published report states 15 were enrolled but 2 dropped out. Gender split: 3/13 were males.
Although 2 out of 7 in the supplement group did not continue taking supplements, they were analysed as ITT.
Interventions High calorie drink to increase energy intake by 20% of predicted energy needs.
Control group received nutritional counselling to increase energy intake by 20% of predicted energy needs by eating high calorie foods.
Outcomes Z scores for weight* and height*, WFH*
Anthropometric measures*
Pulmonary function*
Energy* and nutrient* intake
Faecal balance studies
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quasi‐randomised controlled trial: participants were segregated by age and sex, initial participants from each group randomly allocated to intervention or control (paper does not state how initial randomisation occurred), then each subsequent participant was allocated a different group from the previous one.
Allocation concealment (selection bias) High risk Inadequate, used alternate allocation.
Blinding (performance bias and detection bias)
All outcomes Unclear risk Not possible to blind dietitian or participant ‐ it was stated that apart from the 'study monitors' (nurse and dietitian), all other investigators were blinded, but it was not clear whether all investigators who assessed the outcome measures were blinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk 2 participants dropped out, one in each group after completing baseline (reasons included feeling unwell and change of mind) and were not followed up; 2 out of 7 participants allocated to the supplement group were not taking supplements at 3 months, but were included in the analysis, which was judged to be ITT.
Selective reporting (reporting bias) Unclear risk No adverse events reported; not clear if no events occurred or if not reported.
Did not report the change from baseline values for outcome measures in the original publication, but has since provided summary statistics for the change from baseline to the authors of this review.
Other bias Unclear risk Unable to make clear judgement.