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. 2022 Mar 16;2022(3):CD008524. doi: 10.1002/14651858.CD008524.pub4

Ross 1993 SURVIVAL.

Study characteristics
Methods Cluster‐randomised trial conducted in Ghana
Participants Eligibility: children aged 6–90 months
Excluded: children with xerophthalmia
Sample: 185 clusters that included 21,906 children. 51.5% boys
Interventions Experimental group: vitamin A 100,000 IU for children aged 6–11 months and 200,000 IU for older children + vitamin E 20 IU
Control group: placebo + vitamin E 20 IU
Study duration: intervention delivered every 4 months for 24 months
Outcomes All‐cause mortality and cause‐specific mortality due to diarrhoea, respiratory disease, measles and meningitis; mean vitamin A serum levels; malaria prevalence
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Randomisation was blocked in both studies to ensure similar numbers of children in each group in each part of the study area".
Comment: explicit methods for generating allocation sequence not available.
Allocation concealment (selection bias) Low risk Quote: "Randomisation was carried out in London by an independent statistician, who held the randomisation code and who also did an interim analysis of the mortality results from the Survival Study for the trial's data‐monitoring committee after a year of follow‐up".
Comment: code was protected for the duration of trial.
Blinding (performance bias and detection bias)
Blinding of participants Low risk Quote: "Vitamin A and placebo were supplied by Hoffmann‐La‐Roche's Sight and Life Programme, and were similar in taste and colour. In the Survival Study, liquid vitamin A or placebo was supplied in opaque 150 mL bottles containing 20 IU/mL vitamin E alone (placebo) or plus 100,000 IU/mL retinol equivalent as retinyl palmitate (vitamin A) in purified peanut oil. Each bottle had a unique number, and was labelled with a cluster code before despatch to Ghana".
Comment: probably done.
Blinding (performance bias and detection bias)
Blinding of provider Low risk Comment: as above; probably done.
Blinding (performance bias and detection bias)
Blinding of outcome assessor Low risk Comment: in view of the blinding procedures in place elsewhere in the study, this was probably adequate.
Incomplete outcome data (attrition bias) Unclear risk Comment: 8.4% (1847) children lost to follow‐up and similar between groups. The reasons for losses to follow‐up were not provided.
Selective reporting (reporting bias) High risk Comment: authors collected data on night blindness, Bitot's spots and xerophthalmia, but did not report them.
Other bias Unclear risk Comment: the method for inflating the CIs was not well‐described. No ICC reported