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

Shankar 1999.

Study characteristics
Methods Individually randomised trial conducted in Guinea Bissau
Participants Eligibility: children aged 6–60 months who planned to reside within the study area for ≥ 1 year
Excluded: children with ocular signs of VAD or history of night blindness
Sample: 480 children; 239 in vitamin A group, 241 in control group. 51% boys
Interventions Experimental group: vitamin A 100,000 IU for children aged < 1 year and 200,000 IU for older children + vitamin E 20 IU
Control group: placebo + vitamin E 20 IU
Study duration: intervention given every 4 months for 13 months
Outcomes Incidence of diarrhoea and malaria morbidity, mean vitamin A serum levels
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Within these strata, children were individually allocated vitamin A or placebo in blocks of four (two vitamin A, two placebo) by computer generated randomly permutated codes".
Allocation concealment (selection bias) Low risk Quote: "Capsules were encoded into four groups; two placebo and two vitamin A, and the code was kept offsite by personnel who were not involved in the study".
Blinding (performance bias and detection bias)
Blinding of participants Low risk Comment: identical capsules, and allocation was concealed and code kept off site; described as double‐blind.
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: unlikely that the trained village‐based morbidity worker knew the assignments, however, this is never stated explicitly. Probably done.
Incomplete outcome data (attrition bias) Low risk Quote: "Cross sectional follow‐up rates for mid‐study and end of study were 428 of 480 (89%) and 410 of 480 (85%), respectively, and similar for vitamin A and placebo groups. During the trial two children dropped out, 66 moved out of the study area, and two died".
Comment: intention‐to‐treat used. Missing outcome data balanced in numbers across groups.
Selective reporting (reporting bias) Unclear risk Comment: protocol not referenced and not stated that all measured outcomes were reported. Data at 7 months not completely reported.
Other bias Low risk Comment: no other apparent bias.