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

Biswas 1994.

Study characteristics
Methods Individually randomised, placebo‐controlled trial conducted in Gobinda‐Khatick slum area of eastern Kolkata (formerly Calcutta), India
Participants Eligibility: children aged 12–71 months
Excluded: children with signs of VAD (e.g. xerophthalmia)
Sample: 180 children. Mean age and proportions of boys not specified
Interventions Experimental group: single‐dose vitamin A 200,000 IU in form of retinyl palmitate
Control group: placebo
Follow‐up: 6 months
Outcomes Incidence of diarrhoea and acute respiratory tract infection
Notes The baseline age and nutritional characteristics were similar in both the groups. The surveillance for morbidity outcomes was performed twice monthly. For respiratory disease morbidity, we used data for LRTI only.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "For each strata, a restricted randomisation list was prepared … a random permutated block of block length 6 was used".
Comment: block randomisation by age and weight; probably done.
Allocation concealment (selection bias) Low risk Quote: "… randomisation was done by a pharmacist of the drug manufacturing company".
Comment: assuming that the pharmacist was independent of the study team, this was probably adequate.
Blinding (performance bias and detection bias)
Blinding of participants Low risk Quote: "… identical (colour and taste) placebo. Both drug and placebo were prepared and dispensed in a single dose amber coloured glass ampoule by a local pharmaceutical company".
Blinding (performance bias and detection bias)
Blinding of provider Low risk Quote: "For keeping the trial totally blinded to all participants (for example, patients, investigators, surveyor), randomisation was done by a pharmacist of the drug manufacturing company. Samples of drug (or placebo) were identified by the code number of the respective child".
Blinding (performance bias and detection bias)
Blinding of outcome assessor Low risk Quote: "For keeping the trial totally blinded to all participants (for example, patients, investigators, surveyor), randomisation was done by a pharmacist of the drug manufacturing company. Samples of drug (or placebo) were identified by the code number of the respective child".
Incomplete outcome data (attrition bias) Low risk Quote: "… data was analysed for 174 children due to attrition of 6 children for various reasons (for example, 5 children were hospitalised due to illnesses unrelated to the study objectives and the death of 1 child due post‐measles bronchopneumonia)".
Comment: attrition was low and reported as unrelated to treatment.
Selective reporting (reporting bias) Unclear risk Comment: study protocol was not available to permit a clear judgement. Study aims were to measure diarrhoea and respiratory infection; both outcomes were reported in full in the study report. 1 child died and the treatment group assignment was not disclosed.
Other bias Low risk Comment: study appeared free of other bias.