Coutsoudis 1991.
| Methods | Randomised, double‐blind, placebo‐controlled trial Allocation sequence was generated using a table of random numbers Unit of randomisation was individual participants Treatment and placebo dropper (dispenser bottle) were number‐coded Study duration was 7 months |
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| Participants | Inclusion criteria: measles severe enough to warrant hospital admission, measles cases with pneumonia and diarrhoea, age between 4 and 24 months Exclusion criteria: mild cases of measles (without pneumonia and diarrhoea), children > 24 months, rash > 5 days, vitamin A administration before admission, children with laryngotracheobronchitis |
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| Interventions | Vitamin A versus placebo syrup Investigators used the WHO‐recommended dose for vitamin A (54.5 mg for children < 12 months, 109 mg for children ≥ 12 months) Vitamin A given at admission, on days 2, 8 and 42 Follow‐up was 6 months |
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| Outcomes | Extent of pneumonia, duration of fever, diarrhoea and pneumonia, incidence of herpes stomatitis and laryngotracheobronchitis. Serum zinc, serum vitamin E, serum retinol, serum retinol‐binding protein (RBP), serum albumin and pre‐albumin, weight gain Outcomes were measured on days 8, 42 and 6 months post‐intervention |
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| Notes | Study was carried out in 1989 Normal‐phase, high‐pressure liquid chromatography (HPLC) using fluorescent detection was used to estimate serum retinol level |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Adequate: allocation sequence was generated by table of random numbers |
| Allocation concealment (selection bias) | Low risk | Adequate: treatment and placebo dropper (dispenser bottle) was number‐coded |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Adequate: double‐blind |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Missing outcome data for different outcomes at different times. Differential loss to follow‐up between groups |
| Selective reporting (reporting bias) | Low risk | All pre‐stated outcomes were reported |
| Other bias | Low risk | None known |