Kalnins 2005.

Study characteristics
Methods	Quasi‐RCT. Parallel design with 2 treatment arms. Duration: 6 months (intervention for 3 months and follow‐up to 6 months). Location: Canada.
Participants	Inclusion criteria: adults and children with CF, under 90% weight for height or 5% reduction in weight for height over 3 months. Exclusion criteria: CF‐related diabetes, with a gastrostomy tube CF‐associated liver disease, FEV1 < 30%, oxygen dependence, already receiving routine ONS. Number randomised: 13 participants overall but mixed population of children and adults. Data obtained from authors on participants > 16 years of age (intervention group n = 2, control group n = 3). Attrition: No dropouts from the 5 adults. Gender split: not reported for the 5 adults included. Age: mean (SD) 27.4 (8.4) years. Nutritional status: not reported for the 5 adults included.
Interventions	Intervention (intervention group 1): participants received dietary advice in the form of dietary counselling to increase food intake by 20% of predicted requirements. Intervention (intervention group 2): particpants received ONS in the form of a nutritional supplement to increase energy intake by 20% of predicted requirements.
Outcomes	Survival*, z scores for weight* and height, weight for height, pulmonary function*, energy* intake, REE, faecal balance studies.
Publication details	Language: English. Funding: Mead Johnson Canada. Publication status: peer‐reviewed journal.
Notes	Small trial of supplementation in a mixed population of children and adults with CF. Data obtained from the author on results for adults only.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quasi‐randomised using cards with advice or supplement written on them. The participant selected a card blind. Then the next participant randomised received the other intervention group.
Allocation concealment (selection bias)	High risk	Investigators used alternate allocation.
Blinding (performance bias and detection bias) Clinical outcomes	Low risk	No blind assessment but unlikely that assessment of clinical outcomes would be influenced by lack of blinding.
Blinding (performance bias and detection bias) Functional outcomes	High risk	No blind assessment and likely that assessment of some functional outcomes would be influenced by lack of blinding.
Blinding (performance bias and detection bias) Nutritional outcomes	High risk	No blind assessment and likely that some nutritional outcomes would be 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	Outcomes were not assessed blinded to group allocation and it is likely that assessment of some outcomes would be influenced by lack of blinding.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Reported 2 dropouts, 1 in each group. Study was of mixed ages, information obtained from authors indicated that dropouts were children and not adults, therefore no dropouts amongst the 5 adults included in this review.
Selective reporting (reporting bias)	Unclear risk	No protocol identified. This paper reports outcomes for adults and children combined. Details of mean change (SD) weight and energy intake for the 5 adults have been obtained from the authors.
Other bias	Unclear risk	Baseline variables not given, unsure if groups similar at baseline.