Albert 2003.
Study characteristics | ||
Methods | Factorial design, individually randomised trial conducted in Dhaka, Bangladesh | |
Participants |
Eligibility: children aged 2–5 years of either sex, VAD (serum retinol level < 20 mg/dL; and nutritional status corresponding to a weight‐for‐age score that was 61% of the median National Center for Health Standards standard Excluded: children who had received VAS during the preceding 6 months or with history of night blindness or sickness due to underlying illnesses such as diarrhoea or respiratory tract infections Sample: 256 children |
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Interventions | 4 intervention groups Experimental group I: vitamin A. 5 mL vitamin A syrup 200,000 IU once a week before administration of the first dose of the vaccine and received 5 mL of a placebo syrup every day for 42 days starting 3 weeks before administration of the first dose of vaccine and ending 1 week after the second dose of vaccine Experimental group II: zinc. 5 mL zinc acetate syrup (containing 20 mg of elemental zinc) daily + single dose of a placebo syrup, according to the same schedule used for the children in the A group Experimental group III: vitamin A + zinc Control group: placebo |
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Outcomes | Vibriocidal antibody response to cholera vaccine | |
Notes | No clinical outcomes were available so no data were included in meta‐analysis. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Quote: "Bottles of syrup were serially numbered according to the randomizations list". Comment: most likely done. |
Allocation concealment (selection bias) | Low risk | Quote: "The randomizations code was broken after completion of the study". |
Blinding (performance bias and detection bias) Blinding of participants | Low risk | Quote: "The zinc syrup and its placebo syrup looked very similar, as did the vitamin A syrup and its placebo syrup". |
Blinding (performance bias and detection bias) Blinding of provider | Low risk | Quote: "The randomization code was broken after completion of the study". |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Low risk | Quote: "The randomization code was broken after completion of the study". |
Incomplete outcome data (attrition bias) | Low risk | Comment: minimal attrition. |
Selective reporting (reporting bias) | Unclear risk | Comment: no trial registration number was available. |
Other bias | Low risk | Comment: study appeared free of other bias. |