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

Long 2007.

Study characteristics
Methods Individually randomised trial conducted in Mexico
Participants Eligibility: children aged 5–15 months
Excluded: children who were immunosuppressed; had any congenital abnormality or chronic diarrhoea; history of VAS
Sample: 195 children; 97 in vitamin A group, 98 in placebo group. 49.7% boys
Interventions Experimental group: vitamin A 20,000 IU for children aged < 12 months and 45,000 IU for children aged > 12 months
Control group: placebo
Study duration: intervention repeated every 2 months for 12 months
Outcomes Incidence of diarrhoea and respiratory disease
Notes Baseline sociodemographic characteristics of study children and households were similar between groups. Children received monthly visits and referrals to the doctor, which appeared to exceed normal treatment.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "The randomisation sequence was generated by project personnel based at the National Institute of Public Health".
Comment: probably done.
Allocation concealment (selection bias) Low risk Comment: personnel at the National Institute of Nutrition prepared the supplements to assure that field personnel and the principal investigator were unaware of treatment regimen. Children in the vitamin A and placebo groups received a 5 mL solution, from identical opaque plastic droplet bottles numbered consecutively, administered by the field team.
Blinding (performance bias and detection bias)
Blinding of participants Low risk Quote: "Testing had been carried out at the National Institute of Nutrition to assure that the placebo and vitamin A water miscible solution were similar in taste, viscosity and colour".
Blinding (performance bias and detection bias)
Blinding of provider Low risk Quote: "Personnel at the National Institute of Nutrition carried out the preparation of the supplements to assure that field personnel and the principal investigator were unaware of treatment regimen".
Blinding (performance bias and detection bias)
Blinding of outcome assessor Low risk Quote: "Personnel at the National Institute of Nutrition carried out the preparation of the supplements to assure that field personnel and the principal investigator were unaware of treatment regimen".
Incomplete outcome data (attrition bias) Low risk Comment: unclear what was done with data for 7 missing children, but dropout was small and similar between groups (4 in vitamin A group, 3 in control group).
Selective reporting (reporting bias) Unclear risk Comment: protocol not referenced, though the grant applications may be available.
Other bias Low risk Comment: study appeared free of other bias.