Sommer 1986.
| Methods | Cluster‐randomised trial conducted in a rural area of Indonesia | |
| Participants |
Eligibility: children aged 0‐5 years were included. Children with active xerophthalmia were excluded from the study. Sample: 29,236 children from 450 villages (cluster sites) in Java. 50% of the participants were boys |
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| Interventions | Vitamin A (capsules administered twice over the course of the study: 200,000 IU of vitamin A) was compared with a no treatment control group that served as a waiting list control. 40 IU of vitamin E was also administered with vitamin A. Study duration: 9‐13 months |
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| Outcomes | Mortality, diarrhoea, Bitot's spots, night blindness, xerophthalmia | |
| Notes | ICC not reported (CIs from analyses reported to have been adjusted for design effect). TJL back‐calculated an ICC of 0.008307 from effect estimate provided in paper. Vitamin A was not intended to have been distributed to children under the age of 12 months, but it would appear that some 0‐12 month‐old children received the vitamin A capsule. Outcome data were reported on a cohort of 0‐12 month‐old children. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk |
Quote: "From a random start, 450 villages were systematically selected for the study; these were then randomised for capsule distribution after the baseline examination . . ." Comment: inadequate information provided |
| Allocation concealment (selection bias) | Unclear risk | Comment: inadequate information was presented in order to assess this item in relation to timing of recruitment into the study |
| Blinding (performance bias and detection bias) Blinding of Participants | Unclear risk |
Quote: "The Government of Indonesia would not condone the use of placebos but field‐workers collecting demographic data were unaware that mortality was a research issue." Comment: described as a controlled study, without adequate description of what the control group received |
| Blinding (performance bias and detection bias) Blinding of provider | Unclear risk |
Quote: "The Government of Indonesia would not condone the use of placebos but field‐workers collecting demographic data were unaware that mortality was a research issue." Comment: described as a controlled study, without adequate description of what the control group received |
| Blinding (performance bias and detection bias) Blinding of outcome assessor | Unclear risk |
Quote: "The Government of Indonesia would not condone the use of placebos but field‐workers collecting demographic data were unaware that mortality was a research issue." Comment: described as a controlled study, without adequate description of what the control group received |
| Incomplete outcome data (attrition bias) | Unclear risk |
Quote: "Follow‐up information was available on 89% of the programme children and 88.4% of the controls." Comment: authors indicate percentage remaining per group at follow‐up, but nothing more detailed |
| Selective reporting (reporting bias) | Unclear risk | Comment: trial protocol not available |
| Other bias | Unclear risk | Comment: insufficient information to permit judgement |