Long 2007.
Study characteristics | ||
Methods | Individually randomised trial conducted in Mexico | |
Participants |
Eligibility: children aged 5–15 months Excluded: children who were immunosuppressed; had any congenital abnormality or chronic diarrhoea; history of VAS Sample: 195 children; 97 in vitamin A group, 98 in placebo group. 49.7% boys |
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Interventions |
Experimental group: vitamin A 20,000 IU for children aged < 12 months and 45,000 IU for children aged > 12 months Control group: placebo Study duration: intervention repeated every 2 months for 12 months |
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Outcomes | Incidence of diarrhoea and respiratory disease | |
Notes | Baseline sociodemographic characteristics of study children and households were similar between groups. Children received monthly visits and referrals to the doctor, which appeared to exceed normal treatment. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Quote: "The randomisation sequence was generated by project personnel based at the National Institute of Public Health". Comment: probably done. |
Allocation concealment (selection bias) | Low risk | Comment: personnel at the National Institute of Nutrition prepared the supplements to assure that field personnel and the principal investigator were unaware of treatment regimen. Children in the vitamin A and placebo groups received a 5 mL solution, from identical opaque plastic droplet bottles numbered consecutively, administered by the field team. |
Blinding (performance bias and detection bias) Blinding of participants | Low risk | Quote: "Testing had been carried out at the National Institute of Nutrition to assure that the placebo and vitamin A water miscible solution were similar in taste, viscosity and colour". |
Blinding (performance bias and detection bias) Blinding of provider | Low risk | Quote: "Personnel at the National Institute of Nutrition carried out the preparation of the supplements to assure that field personnel and the principal investigator were unaware of treatment regimen". |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Low risk | Quote: "Personnel at the National Institute of Nutrition carried out the preparation of the supplements to assure that field personnel and the principal investigator were unaware of treatment regimen". |
Incomplete outcome data (attrition bias) | Low risk | Comment: unclear what was done with data for 7 missing children, but dropout was small and similar between groups (4 in vitamin A group, 3 in control group). |
Selective reporting (reporting bias) | Unclear risk | Comment: protocol not referenced, though the grant applications may be available. |
Other bias | Low risk | Comment: study appeared free of other bias. |