Vijayaraghavan 1990.
Study characteristics | ||
Methods | Cluster‐randomised study in rural India | |
Participants |
Eligibility: children aged 1–5 years Excluded: children with corneal involvement Sample: 15,775 children in 84 clusters. 50.4% boys |
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Interventions |
Experimental group: vitamin A 200,000 IU given twice Control group: placebo (arachis oil) Study duration: unclear |
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Outcomes | Mortality, diarrhoea, acute respiratory infections, measles | |
Notes | Respiratory infection has non‐specific definition of "clinically significant cough". | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: "The villages were allocated randomly into two groups‐treatment and control". Comment: insufficient detail to form a judgement. |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient detail provided. |
Blinding (performance bias and detection bias) Blinding of participants | Low risk | Quote: "The trial was double blind: the investigators and medical officers did not know which were the treatment and which were the control areas. They were not aware whether the dose they were distributing was vitamin A or placebo. Decoding was done only after data had been collected". |
Blinding (performance bias and detection bias) Blinding of provider | Low risk | Comment: as above; probably done. |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Low risk | Comment: as above; probably done. |
Incomplete outcome data (attrition bias) | Unclear risk | Comment: insufficient detail provided. |
Selective reporting (reporting bias) | High risk | Comment: incidence of infections outcome not given with respect to vitamin A and control groups. Given according to the clinical vitamin A status of all the study children. |
Other bias | Low risk | Comment: study appeared free of other bias. |