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%. |
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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. |