Chowdhury 2002.
Study characteristics | ||
Methods | Individually randomised trial conducted in urban slums of Chandigarh, India | |
Participants |
Eligibility: children aged < 10 years Excluded: children with xerophthalmia and history of VAS Sample: 1520 children; 756 to vitamin A group, 759 to placebo group. Mean age 51 months. 50% boys |
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Interventions |
Experimental group: vitamin A 50,000 IU for children aged < 6 months; 100,000 IU for children aged 6–12 months and 200,000 IU for children aged > 1 year Control group: placebo Study duration: intervention given every 4 months for 15 months |
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Outcomes | All‐cause mortality; cause‐specific mortality due to diarrhoea, pneumonia, and meningitis; incidence of diarrhoea, pneumonia, and measles. Measurement of subclinical VAD status was by conjunctival impression cytology | |
Notes | Baseline sociodemographic and anthropometric characteristics were similar in both the groups. Study population had a high prevalence of VAD. Children were contacted every 15 days by home visits to obtain information on morbidity and mortality. Study included children aged < 10 years; however, the mean age of the children was 51 months. Study methods were not explicitly described. According to WHO, India is a country with a high child mortality rate (i.e. > 40/1000). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "From three slums of Chandigarh, 1520 non‐xerophthalmic children of less than 10 years of age were individually randomised in equal number to receive vitamin A or placebo". |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to permit judgement. |
Blinding (performance bias and detection bias) Blinding of participants | Unclear risk |
Quote: "An equivalent volume of arachis oil was given as placebo". Comment: insufficient information to permit judgement. |
Blinding (performance bias and detection bias) Blinding of provider | Unclear risk | Comment: insufficient information to permit judgement. |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Unclear risk | Comment: insufficient information to permit judgement. |
Incomplete outcome data (attrition bias) | High risk | Comment: although attrition rates were balanced, the rates of mortality were lower than the rate of withdrawal. This could impact on the reliability of the results. |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to permit judgement. |
Other bias | Unclear risk | Comment: study not sufficiently reported in order to assess this item fully. |