Hanning 1993.
Study characteristics | ||
Methods | Random allocation using sealed envelopes.
Parallel design, no intention‐to‐treat analysis. Duration: 6 months. Location: single centre in Canada. |
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Participants | 20 children with CF and mild to moderate lung disease, aged 7 ‐ 15 years. Lung function (FEV₁ % predicted) (mean (SD)): control group 84.2% (26.3); supplemented group 101.4% (19.4). % WFH (mean (SD)); control group 95.6% (12.1); supplement group 92.8% (11.3). 20 randomised (12 males), 16 (10 males) studied. |
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Interventions | Dietary supplements, drink powders, milk shakes, tinned puddings to achieve 25% of normal energy recommendations in addition to normal diet. No intervention in control groups. | |
Outcomes | Skeletal muscle strength and power Pulmonary function* and respiratory muscle strength Height*, weight* and anthropometric measurements* Habitual physical activity Body composition Dietary energy* and nutrient intake* Energy* and nutrient* intake from supplements Laboratory measures of nutritional status (e.g. albumin, amino acids) | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random allocation using based on a table of random numbers. |
Allocation concealment (selection bias) | Low risk | Used sealed envelopes. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Investigators performing skeletal and lung muscle‐function tests and anthropometry were unaware of the participant's study group. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No ITT analysis. 20 randomised, 16 studied. Four participants did not complete the trial because they found the time demands for testing or the travelling distance to be excessive. |
Selective reporting (reporting bias) | Unclear risk | No adverse events reported; not clear if no events occurred or if not reported. |
Other bias | High risk | The treated group appeared to be in better clinical condition at baseline. |