Lin 2008.
Study characteristics | ||
Methods | Randomised, placebo‐controlled trial conducted in Wuhan, an industrial centre in central region of China | |
Participants |
Eligibility: children aged 2–7 years. Children were recruited from kindergarten in the area Excluded: children with fever, diarrhoea or a recent preventive injection; underweight children with BMI age‐ and sex‐specific 5th percentile of the first US National Health and Nutrition Examination Survey data; children whose protein or energy intake met Chinese RDA Sample: 105 children. Mean age 55 months. 61% boys |
|
Interventions | 3 intervention groups. 2 consisted of children who were vitamin A deficient and 1 with children who were vitamin A sufficient. Experimental group I (vitamin A deficient): vitamin A 100,000 IU every month for 3 months Control group I (vitamin A deficient): placebo Control group II (vitamin A sufficient): placebo |
|
Outcomes | All‐cause mortality, mean serum vitamin A levels | |
Notes | We 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 third group that is clearly matched. This may not be a randomised controlled trial. |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient detail provided to make a 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 a 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 could be analysed. |
Other bias | Unclear risk | Comment: as blinding was not described, potential performance bias and other sources of bias could not be assessed. |