Chen 2013a.
Methods | Factorial design, individually randomised trial conducted in Chengdu City, China | |
Participants |
Eligibility: children aged 3‐6 years, apparently good health, haemoglobin (Hb) concentration > 60 g/L, serum C‐reactive protein (CRP) < 10 mg/L, parental or guardian's approval for participation and parental or guardian's agreement to avoid additional use of vitamin A and iron supplements during the investigation were eligible for inclusion. Children with evidence of recent acute or chronic illnesses and/or Hb <60 g/L were excluded. Sample: 387 children were included in the study |
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Interventions | 4 groups:
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Outcomes | Incidence of diarrhoea and LRTI | |
Notes | The study setting was a periurban area in Huayuan Town, Pixian County of Chengdu City, Sichuan Province, western China, from March to September 2011. Supplementation was given in schools. The paper did not have a study flow diagram. The data from the factorial design were included in 2 data sets. The first data set (Chen 2013a) is the comparison between Vitamin A and placebo while the second data set (Chen 2013b) is the comparison between vitamin A + iron vs iron only. The data for meta‐analysis was taken from table 2 and we calculated the rate ratio based on the number of events in the intervention and control groups with the denominator as person‐days at risk. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The RAND function of Excel (Microsoft, Redmond,WA, USA) was used to generate computer randomly permutated codes" |
Allocation concealment (selection bias) | Low risk |
Quote: "The health care workers, outcome assessors, data analyst and children were not made aware of the intervention assignment until the completion of data analysis." Comment: probably done |
Blinding (performance bias and detection bias) Blinding of Participants | Low risk | Quote: "Children were not made aware of the intervention". |
Blinding (performance bias and detection bias) Blinding of provider | Low risk | Quote: "The health care workers, outcome assessors, data analyst and children were not made aware of the intervention. . ." |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Low risk | Quote: ". . . outcome assessors, data analyst and children were not made aware of the intervention . . ." |
Incomplete outcome data (attrition bias) | Low risk | Comment: loss to follow‐up was 13% and balanced in each group with similar reasons for attrition. |
Selective reporting (reporting bias) | Unclear risk | Comment: the trial registration number was not given. Authors do mention that they could not report some of the a priori mentioned serum biochemical markers, as they could not collect enough blood samples. |
Other bias | Low risk | Comment: the study seems to be free of other bias. |