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. |