Kartasasmita 1995.
Study characteristics | ||
Methods | Individually randomised trial conducted in a suburban community of city Bandung, Indonesia | |
Participants |
Eligibility: children aged 12–54 months Excluded: not specified Sample: 269 children; 126 children in vitamin A group, 141 children in control group. Mean age 33 months. 51% boys |
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Interventions |
Experimental group: vitamin A 200,000 IU once every 6 months for 12 months Control group: placebo |
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Outcomes | Incidence of respiratory disease, mean serum retinol levels | |
Notes | Authors presented data on respiratory outcomes according to severity of disease. We 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 judgement. |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient details provided to make a 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 a judgement. |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Unclear risk | Comment: insufficient detail provided to make a 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 a judgement. |
Other bias | Unclear risk | Comment: methods of study were not described very clearly. |