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. 2022 Mar 16;2022(3):CD008524. doi: 10.1002/14651858.CD008524.pub4

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
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
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.