Pinnock 1986.
Methods | Individually randomised study in urban area of Australia | |
Participants |
Eligibility: children aged 1‐4 years of age in 3 general practices from Adelaide. Children with more than 15 days of cough or 3 separate episodes of respiratory illness during the preceding 3 months were eligible. Sample: 147 children were randomised to the treatment groups. Mean age was 39.3 months. 50% of participants were boys |
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Interventions | Vitamin A administered orally as retinyl palmitate, 1160 mcg 3 times per week for 20 weeks, versus placebo | |
Outcomes | Acute respiratory infections, pneumonia, mean serum vitamin A | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Quote: "Randomization of treatment was achieved by combining active and placebo bottles in a sequence, which was determined by consulting a table of random numbers, and numbering the bottles accordingly." Comment: probably done |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to permit judgment |
Blinding (performance bias and detection bias) Blinding of Participants | Low risk | Quote: "The placebo was a similarly constituted syrup omitting retinyl palmitate and labelled and bottled identically." |
Blinding (performance bias and detection bias) Blinding of provider | Low risk | Quote: "All staff connected with the study remained blind to the identity of the child's medication." |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Low risk | Quote: "All staff connected with the study remained blind to the identity of the child's medication." |
Incomplete outcome data (attrition bias) | Low risk | Comment: a high rate of attrition, but reasons for withdrawal given and that there were no significant changes in the distribution of major potential confounding factors between the 2 groups. |
Selective reporting (reporting bias) | Unclear risk | Comment: protocol not available |
Other bias | Low risk | Comment: no other apparent bias was observed. |