Lin 2008.
Methods | Randomised, placebo‐controlled trial conducted in Wuhan, an industrial centre in central region of China | |
Participants |
Eligibility: inclusion criteria was age 2‐7 years. Children were recruited from kindergarten in the area. Those who had fever, diarrhoea or a recent preventive injection were excluded from the study. Underweight children with BMI age‐ and sex‐ specific 5th percentile of the first US National Health and Nutrition Examination Survey data were excluded. Children whose protein or energy intake met Chinese RDA were also excluded. Sample: 105 children were randomised to 3 intervention groups (described below). Mean age of study participants was 55 months, and proportion of boys was 61% |
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Interventions | There were 3 study groups. 2 of these consisted of children who were vitamin A deficient and 1 with children who were vitamin A sufficient. Vitamin A was given only to children in 1 of the vitamin A deficient groups in a dose of 100,000 IU every month for 3 months. The other 2 groups received placebo. | |
Outcomes | All‐cause mortality, mean serum vitamin A levels | |
Notes | In this review, we have included data for vitamin A deficient children who were either supplemented with vitamin A or placebo. According to WHO, China does not have a high child mortality rate (i.e. < 40/1000). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: "The remaining 70 vitamin A‐deficient children were randomly and equally divided into vitamin A deficient‐supplemented group and vitamin A‐deficient placebo group." Comment: the term 'randomised' is also used to describe a 3rd group that is clearly matched. This may not be an RCT. |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient detail provided to make judgement |
Blinding (performance bias and detection bias) Blinding of Participants | Low risk | Quote: "Children of vitamin A‐deficient‐supplemented group were given 100 000 IU (retinol equivalent) vitamin A capsules every 2 weeks for 3 months (Grubesic, 2004). Children of vitamin A‐sufficient placebo group and vitamin A‐deficient placebo group received placebo capsules in the same way." |
Blinding (performance bias and detection bias) Blinding of provider | Unclear risk | Comment: although study was double randomised trial, no details of how blinding was achieved was described in the district |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Unclear risk | Comment: insufficient detail provided to make judgement |
Incomplete outcome data (attrition bias) | Low risk | Comment: no attrition reported |
Selective reporting (reporting bias) | High risk | Comment: main outcome data not reported in a manner that can be analysed |
Other bias | Unclear risk | Comment: as blinding is not described, potential performance bias and other sources of bias cannot be assessed |