Shankar 1999.
Study characteristics | ||
Methods | Individually randomised trial conducted in Guinea Bissau | |
Participants |
Eligibility: children aged 6–60 months who planned to reside within the study area for ≥ 1 year Excluded: children with ocular signs of VAD or history of night blindness Sample: 480 children; 239 in vitamin A group, 241 in control group. 51% boys |
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Interventions |
Experimental group: vitamin A 100,000 IU for children aged < 1 year and 200,000 IU for older children + vitamin E 20 IU Control group: placebo + vitamin E 20 IU Study duration: intervention given every 4 months for 13 months |
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Outcomes | Incidence of diarrhoea and malaria morbidity, mean vitamin A serum levels | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Within these strata, children were individually allocated vitamin A or placebo in blocks of four (two vitamin A, two placebo) by computer generated randomly permutated codes". |
Allocation concealment (selection bias) | Low risk | Quote: "Capsules were encoded into four groups; two placebo and two vitamin A, and the code was kept offsite by personnel who were not involved in the study". |
Blinding (performance bias and detection bias) Blinding of participants | Low risk | Comment: identical capsules, and allocation was concealed and code kept off site; described as double‐blind. |
Blinding (performance bias and detection bias) Blinding of provider | Low risk | Comment: as above; probably done. |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Low risk | Comment: unlikely that the trained village‐based morbidity worker knew the assignments, however, this is never stated explicitly. Probably done. |
Incomplete outcome data (attrition bias) | Low risk |
Quote: "Cross sectional follow‐up rates for mid‐study and end of study were 428 of 480 (89%) and 410 of 480 (85%), respectively, and similar for vitamin A and placebo groups. During the trial two children dropped out, 66 moved out of the study area, and two died". Comment: intention‐to‐treat used. Missing outcome data balanced in numbers across groups. |
Selective reporting (reporting bias) | Unclear risk | Comment: protocol not referenced and not stated that all measured outcomes were reported. Data at 7 months not completely reported. |
Other bias | Low risk | Comment: no other apparent bias. |