Chen 2013a.
Study characteristics | ||
Methods | Factorial design, individually randomised trial conducted in Chengdu City, China | |
Participants |
Eligibility: children aged 3–6 years, apparently good health, haemoglobin concentration > 60 g/L, serum C‐reactive protein < 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 Excluded: children with evidence of recent acute or chronic illnesses or haemoglobin < 60 g/L (or both) Sample: 387 children |
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Interventions | 4 intervention groups Experimental group I: vitamin A 200,000 IU capsule (as retinol) just once initially Experimental group II: ferrous sulphate (elemental iron 1–2 mg/kg) once daily for 6 months Experimental group III: vitamin A 200,000 IU capsule once initially and ferrous sulphate (elemental iron 1–2 mg/kg) once daily for 6 months Control group: neither vitamin A nor ferrous sulphate |
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Outcomes | Incidence of diarrhoea and LRTI | |
Notes | 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 is the comparison between vitamin A and placebo (Chen 2013a), while the second data set is the comparison between vitamin A + iron vs iron only (Chen 2013b). The data for meta‐analysis was taken from table 2 and we calculated the rate ratio based on the number of events in the experimental 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 did 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: study appeared free of other bias. |