Bahl 1999.
Study characteristics | ||
Methods | Individually randomised study conducted in an urban slum of Delhi, India | |
Participants |
Eligibility: infants aged 6–9 months enrolled into study when they turned 9 months old Excluded: infants with history of measles, contact with a case of measles or measles immunisation, or had received a dose of vitamin A in the previous 4 months; serious illness requiring hospitalisation or having clinical signs of VAD (i.e. xerophthalmia, Bitot's spots, etc.) Sample: 618 infants; 309 in vitamin A group, 309 in control group. 50% boys |
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Interventions |
Experimental group: single‐dose vitamin A 30 mg (100,000 IU) in the form of retinol palmitate Control group: soybean oil Follow‐up: 4 months |
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Outcomes | Antibody response to measles vaccine, incidence of measles during study period, and side effects (e.g. vomiting, drowsiness, etc.) in first 48 hours | |
Notes | The primary objective of the study was to determine the response to measles vaccine when administered along with vitamin A at 9 months of age. The study found no significant difference in antibody titres between groups 3 months after the administration of intervention. The baseline prevalence of clinical VAD in children aged 1–5 years in the study area was 3.5% and that of biochemical VAD was 37%. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk |
Quote: "Infants were randomly assigned to receive vitamin A or a placebo by using a simple randomisation scheme with random permuted blocks of size eight, i.e. four infants each out of every eight infants enrolled were randomised to receive vitamin A or a placebo". Comment: probably done. |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to permit judgement. |
Blinding (performance bias and detection bias) Blinding of participants | Low risk |
Quote: "This scheme ensured that all infants received 30 mg vitamin A by 12 mo [months] of age without interfering with the double‐blind design of the study". Comment: probably done. |
Blinding (performance bias and detection bias) Blinding of provider | Low risk | Comment: adequate masking of vitamin A and placebo should have meant that providers were adequately blinded. |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Low risk | Comment: adequate masking of vitamin A and placebo should have meant that outcome assessors were adequately blinded. |
Incomplete outcome data (attrition bias) | High risk | Comment: losses to follow‐up and exclusions described. Missing data excluded from the analysis. It is not possible to ascertain whether the exclusion of data from 17% of participants (equally distributed between treatment groups) would have impacted on the results. The investigators stated that the reason for their exclusion was that a follow‐up serum sample could not be ascertained. |
Selective reporting (reporting bias) | High risk | Comment: data on harms are incompletely disclosed in the study report. |
Other bias | Low risk | Comment: study appeared free of other bias. |