Pinnock 1988.
Study characteristics | ||
Methods | Individually randomised study in urban area of Australia | |
Participants |
Eligibility: children aged 0–2 years with history of bronchiolitis and nasal culture positive for RSV Excluded: children taking vitamin A; children with cystic fibrosis, cardiopulmonary difficulties, major brain dysfunctions Sample: 206 children. Mean age 58 months. 60% boys |
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Interventions |
Experimental group: vitamin 4.2 mg per week as retinyl palmitate for 12 months Control group: placebo |
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Outcomes | Diarrhoea, diarrhoea‐related hospitalisation, acute respiratory infections, pneumonia, pneumonia‐related hospitalisation, mean serum vitamin A | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Quote: "Randomization was achieved by randomly allocating four of eight batch numbers to vitamin A supplement and the remaining four to placebo". Quote: "the batch number code was retained by the manufacturer". |
Allocation concealment (selection bias) | Low risk |
Quote: "The batch number code was retained by the manufacturer. The bottles were then distributed sequentially according to batch number as children presented …". Comment: probably done. |
Blinding (performance bias and detection bias) Blinding of participants | Low risk |
Quote: "The placebo had an identical appearance and formulation except for the active ingredient". Comment: probably done. |
Blinding (performance bias and detection bias) Blinding of provider | Low risk | Quote: "Both investigators and parents were blind as to the treatment status of the child". |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Low risk | Quote: "Both investigators and parents were blind as to the treatment status of the child … The batch number code was retained by the manufacturer". |
Incomplete outcome data (attrition bias) | Low risk | Comment: complete details of those excluded and lost to follow‐up were provided. |
Selective reporting (reporting bias) | High risk | Comment: outcomes mentioned in methods not reported in results. |
Other bias | Low risk | Comment: study appeared free of other bias. |