Rahman 2001.
Methods | Individually randomised study conducted in an urban area of Bangladesh | |
Participants |
Eligibility: children aged 12‐35 months were eligible for inclusion in the study. Children who had received vitamin A within the previous 4 months; had severe malnutrition, with signs or symptoms of vitamin A or zinc deficiency; or with any systemic illness such as diarrhoea, respiratory infection, fever, or any other illness that warranted medical intervention at the time of enrolment were excluded. Sample: 800 children were enrolled (200 in each of the 4 treatment groups). Mean age of participants was between 23.5 and 24.2 months across the treatment groups. 56% of the participants were boys |
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Interventions | There were 4 treatment groups:
Study duration: 6 months |
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Outcomes | Diarrhoea, acute respiratory infections, serum vitamin A levels, and vitamin deficiency | |
Notes | Data on treatment analysis was not presented. We have written to authors for data on each treatment arm. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Quote: "The children were randomly assigned by a person not involved in the study who used permuted blocks of random numbers." Comment: probably done |
Allocation concealment (selection bias) | Low risk |
Quote: "Sets of 2 bottles and 1 capsule for each child were serially numbered . . . A local pharmaceutical company prepared the study syrups (zinc and placebo) which were supplied in identical 50‐mL bottles . . . The vitamin A and placebo capsules looked identical." Comment: probably done |
Blinding (performance bias and detection bias) Blinding of Participants | Low risk |
Quote: "The zinc and placebo syrups were supplied in bottles that looked identical, and the appearance and consistency of the syrups were similar. Vitamin A and placebo capsules were identical in appearance." Comment: probably done |
Blinding (performance bias and detection bias) Blinding of provider | Low risk |
Quote: "The randomisation code was kept sealed until the completion of the study." Comment: identical presentation; probably done |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Low risk | Quote: "The treatment allocations were disclosed after the final analysis." |
Incomplete outcome data (attrition bias) | Low risk | Comment: data on loss to follow‐up given and also stated that the baseline characteristics of children who were excluded or lost to follow‐up were comparable to those of the children who continued in the study. |
Selective reporting (reporting bias) | Unclear risk | Comment: protocol not available |
Other bias | Low risk | Comment: no other apparent bias |