Kartasasmita 1995.
| Methods | Individually‐randomised trial conducted in a suburban community of city Bandung, Indonesia | |
| Participants |
Eligibility: children aged 12‐54 months were included in the study. No exclusion criteria were specified. Sample: 269 children were randomised either to vitamin A or placebo group. The vitamin A supplemented group had 126 children while the placebo group had 141 children. Mean age of study participants was 33 months, and proportion of boys was 51% |
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| Interventions | The experimental group received 200,000 IU of vitamin A once every 6 months for 12 months. The comparison group received placebo only. | |
| Outcomes | Incidence of respiratory disease, mean serum retinol levels | |
| Notes | Authors presented data on respiratory outcomes according to severity of disease. We have included data for "severe respiratory disease" only. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote: "The children were selected by randomised stratified sampling from the almost 2000 under‐fives residing in Cikutra." Comment: insufficient details available to make a judgment |
| Allocation concealment (selection bias) | Unclear risk | Comment: insufficient detail provided to make judgement |
| Blinding (performance bias and detection bias) Blinding of Participants | Unclear risk | Quote: "All children participated in an age‐ and sex‐matched randomised, double blind vitamin A supplementation programme by receiving vitamin A 200,000 IU or placebo capsules orally, at the start and at the 6th month of the study." |
| Blinding (performance bias and detection bias) Blinding of provider | Unclear risk | Comment: insufficient detail provided to make judgement |
| Blinding (performance bias and detection bias) Blinding of outcome assessor | Unclear risk | Comment: insufficient detail provided to make judgement |
| Incomplete outcome data (attrition bias) | High risk | Comment: insufficient reporting of attrition/exclusions to permit judgement |
| Selective reporting (reporting bias) | Unclear risk | Comment: insufficient detail provided to make judgement |
| Other bias | Unclear risk | Comment: the methods of the study are not described very clearly |