Rosale 1996.
Methods | Randomised controlled, double‐blind trial Allocation sequence generated by table of random numbers Unit of randomisation: individual participants Study duration was 7 months |
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Participants | Inclusion criteria: prodromal or effervescent measles, consent by parents, confirmation by a four‐fold increase in measles antibody titre at end of week 2 Exclusion: cases requiring hospitalisation, xerophthalmia, severe undernutrition, refusal to give consent by parents |
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Interventions | Vitamin A in oil given as a single dose of 210 μmol (200,000 IU) with vitamin E (42.4 microgram) versus placebo Co‐interventions: eye ointment, paracetamol, aspirin, tetracycline, intramuscular penicillin, oral rehydration fluids, gentian violet, cough mixture Follow‐up was for 4 weeks |
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Outcomes | Cough, pneumonia, serum retinol level, nutritional status Outcomes were measured 2 weeks and 42 days post‐intervention |
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Notes | Both nutritional status and eye examination were reportedly done at follow‐up visits. In a feedback communication, the author (Frasisco Rosale) indicated that "....undernutrition remained unchanged throughout the study period and did not differ significantly between the two groups" and that "......no cases of conjunctivitis was observed in both groups throughout the follow‐up period" Serum retinol levels were determined by high‐pressure, liquid chromatography |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Adequate: sequence was generated using a table of random numbers |
Allocation concealment (selection bias) | Low risk | Adequate: codes were used on bottles |
Blinding (performance bias and detection bias) All outcomes | Low risk | Adequate: double‐masking of the dispenser bottles which were also number‐coded |
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) | High risk | Eye examination and conjunctival impression cytology done but we do not have access to information on cytology examination |
Other bias | Low risk | None known |
IU: international units