Hanning 1993.
Methods | Randomised controlled study. Duration: 6 months (follow up of a subset of participants for a further 3 months). Parallel design. Single centre. Location: Canada. No intention‐to‐treat analysis. |
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Participants | 20 children with CF and mild to moderate lung disease aged 7 ‐ 15 years.
Randomised n = 20 (10 treatment group, 10 control group).
Gender split: treatment group 7 males, 3 females; control group 5 male, 5 female. Mean (SD) age: treatment group 10.7 (2.4) years; control group 10.0 (2.8) years. Studied n = 16 (9 treatment group, 7 control group). Gender split: treatment group 6 male, 3 females; control group 4 males, 3 females. Mean (SD) age: treatment group 10.6 (2.5) years; control group 9.5 (2.9) years. |
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Interventions | Treatment: dietary supplements, drink powders, milk shakes, tinned puddings, to achieve 25% of normal energy recommendations in addition to normal diet. Control: no intervention. | |
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 | Number enrolled was slightly less than the sample size of 24 investigators had estimated they needed. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Paper states that participants were randomly allocated to treatment or control ordered on the basis of a table of random numbers. |
Allocation concealment (selection bias) | Low risk | Paper states that participants selected a card from within a sealed envelope. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Not explicitly discussed in paper. Groups were dietary supplement or no supplement, so participants at least could not be blinded. Outcomes were not affected by blinding. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons for 4 participants not completing trial given (the time demands for testing or the travelling distance found to be excessive). |
Selective reporting (reporting bias) | Unclear risk | Paper appears to address all the outcomes measured in the 'Resuts' section. No access to study protocol to double check. |