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. 2017 Mar 10;2017(3):CD008524. doi: 10.1002/14651858.CD008524.pub3

Daulaire 1992.

Methods Cluster‐randomised, non‐placebo controlled trial conducted in Jumla district, Nepal
Participants Eligibility: children aged 1‐59 months were eligible for inclusion in the trial.
Sample: 16 clusters were randomly assigned either to vitamin A or control group. These included 7197 children, of which 3786 children were in the vitamin A group and 3411 were in the control group. Proportion of boys was 51%.
Interventions In experimental group, vitamin A was given in doses of 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 old. Vitamin A was supplemented once only and children were followed for 5 months
Outcomes All‐cause mortality and cause‐specific mortality due to diarrhoea, pneumonia, and measles
Notes The 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 one of the poorest and most medically underserved areas of the country. The 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 suffering from substantial malnutrition. A survey of 3651 children under 5 years of age showed active xerophthalmia in 1.3% to 2% of population and 1% to 5% among infants, which is high for this age group. Disaggregated data on mortality was available according to different age groups. We have 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 judgment
Other bias Low risk Comment: this study appears to be free of other bias.