Random sequence generation (selection bias) |
Low risk |
Quote: "We randomly assigned infants to receive either vitamin A or a placebo. The unit of randomisation was the individual infant. Block randomisation was done at WHO (Geneva, Switzerland) in block sizes of 20 (ten infants received vitamin A and ten received placebo)" |
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Comment: Most likely done |
Allocation concealment (selection bias) |
Low risk |
Quote: "The vitamin A and placebo capsules were identical in taste and appearance. Capsules were individually packed in blister packs of two capsules each; one for the dose and the second for the backup dose. Labels for the capsules were printed at WHO with country and infant study number in sequential order" |
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Comment: Most likely done |
Blinding of participants and personnel (performance bias) |
Low risk |
Quote: "Codes for the experimental regimens were kept with the data and safety monitoring board and broken during the analysis after a cleaned and locked database for the study was submitted to WHO" |
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Comment: Most likely done |
Blinding of outcome assessment (detection bias) |
Low risk |
Quote: "All reported deaths of children were investigated and trained field staff visited the family at least 6 weeks after the date of death to do a verbal autopsy interview" |
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"Trained field interviewers visited enrolled infants at home (or in health facilities for cases in which the mother and child were not discharged after delivery) 1 day and 3 days after dosing to monitor possible adverse events after supplementation" |
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Comment: Most likely done |
Incomplete outcome data (attrition bias) |
Unclear risk |
Total number of loss to follow up: n (%) |
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The loss to follow up was not balanced |
Selective reporting (reporting bias) |
Low risk |
Authors seem to report all the relevant outcomes |
Other bias |
Low risk |
No other risk of bias was noted |