Renner 2001.
Methods | Randomised, double‐blind placebo controlled trial. Study based in Vienna, Austria. |
|
Participants | 24 participants with CF from 1 unit in Vienna. 13 (9 female) randomised to supplementation (mean age 12.8 years; range 6.8 ‐ 27.7) and 11 (9 female) randomised to placebo (mean age 10.5 years; range 6.7 ‐ 17.3). | |
Interventions | 3‐month 'high dose supplementation' of β‐carotene at 1 mg/kg/day followed by low dose regimen of 10mg/day for 3 months vs starch‐containing placebo. | |
Outcomes | Primary outcomes ‐ normalised plasma concentration of β‐carotene; number of pulmonary exacerbations, lung function. | |
Notes | No specific data regarding bacteria presented ‐ author contacted for more information 26 Jan 10. The control group was on average 2.3 years younger than the intervention group. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but method of randomisation not described. |
Allocation concealment (selection bias) | Unclear risk | Capsules were of identical appearance. Procedure for dispensing preparation unclear. |
Blinding (performance bias and detection bias) PUFA first | Low risk | Described as 'double‐blind' but method not described. Capsules were of identical appearance. Rust 2000: Described as double blind but no further detail. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There were no drop‐outs. Two publications for this trial appear to report separate outcome data. |
Selective reporting (reporting bias) | Low risk | Selective reporting not identified other than the separate reporting of different outcome data. |
Other bias | Unclear risk | Patient compliance not reported. |