Daulaire 1992.
Study characteristics | ||
Methods | Cluster‐randomised, non‐placebo‐controlled trial conducted in Jumla district, Nepal | |
Participants |
Eligibility: children aged 1–59 months Sample: 16 clusters randomly assigned. 7197 children; 3786 in vitamin A group, 3411 in control group. 51% boys |
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Interventions |
Experimental group: single‐dose vitamin A 200,000 IU for children aged 12–59 months; 100,000 IU for children aged 6–12 months; and 50,000 IU for children aged < 6 months Control group: treatment as usual Follow‐up: 5 months |
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Outcomes | All‐cause mortality and cause‐specific mortality due to diarrhoea, pneumonia, and measles | |
Notes | Study site was a remote, mountainous region of northwestern Nepal with a total population of about 80,000, with 12,000 children under 5 years of age. This area was considered as 1 of the poorest and most medically underserved areas of the country. Infant mortality rate was 189 deaths per 1000 live births and child (1–4 years) mortality rate was 52 per 1000 per year. Malnutrition was prevalent in the study area, and 26% of children aged 1–4 years were experiencing substantial malnutrition. A survey of 3651 children aged < 5 years showed active xerophthalmia in 1.3–2% of population and 1–5% among infants, which is high for this age group. Disaggregated data on mortality were available according to different age groups. We used data for children aged 6–59 months according to the objectives of our review. According to WHO, Nepal is a country with a high child mortality rate (i.e. > 40/1000). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Quote: "We randomly selected by card eight of the 16 sub‐districts for vitamin A supplementation". Comment: probably done. |
Allocation concealment (selection bias) | High risk |
Comment: author contacted and replied. Quote from author: "No effort was made to conceal the allocation sequence". |
Blinding (performance bias and detection bias) Blinding of participants | High risk | Quote: "There was no placebo or blinding". |
Blinding (performance bias and detection bias) Blinding of provider | High risk | Quote: "There was no placebo or blinding". |
Blinding (performance bias and detection bias) Blinding of outcome assessor | High risk | Quote: "There was no placebo or blinding". |
Incomplete outcome data (attrition bias) | Low risk | Comment: there was no loss to follow‐up; coverage of intervention described in detail. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to permit judgement. |
Other bias | Low risk | Comment: study appeared free of other bias. |