Arya 2000.
| Methods | Individually‐randomised trial conducted in New Delhi, India | |
| Participants |
Eligibility: infants aged 9‐12 months attending the immunisation clinic of Safdurjung hospital in New Delhi were eligible for inclusion in the trial. Sick infants requiring hospitalisation excluded Sample: 256 infants, with equal numbers (i.e. 128) in vitamin A and placebo group. Mean age of participants was 9 months |
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| Interventions | The experimental group received a single dose of 100,000 IU of vitamin A in arachis oil. The control group received placebo in peanut oil. Both vitamin A and placebo were administered at the time of measles vaccination. At the end of the study, the vitamin A group received placebo, and the placebo group received vitamin A. | |
| Outcomes | Incidence of side effects in first 24 hours (vomiting, loose motions, fever, irritability, bulging fontanelle) | |
| Notes | Study participants were not significantly different in sex, age, and weight distribution, and nutritional status at the baseline.The baseline prevalence of vomiting, loose stools, fever, and irritability during the 24 hours prior to dosing was similar in both groups. 97.3% of the included infants had normal serum retinol level before the study. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk |
Quote: "The infants were randomised . . . according to the order of arrival at hospital. Randomisation was done by the nurse who gave measles vaccine to these children." Comment: probably not done |
| Allocation concealment (selection bias) | Unclear risk | Comment: children were randomised according to their entry into hospital |
| Blinding (performance bias and detection bias) Blinding of Participants | Low risk | Quote: "This double‐blind, randomised . . . supplied in small dark bottles marked '1' and '2'." |
| Blinding (performance bias and detection bias) Blinding of provider | Low risk | Quote: "This double‐blind, randomised . . . supplied in small dark bottles marked '1' and '2'." |
| Blinding (performance bias and detection bias) Blinding of outcome assessor | Low risk | Quote: "This double‐blind, randomised . . . supplied in small dark bottles marked '1' and '2' . . . Two clinicians examined each of the infants at both first and second visits. Neither clinician knew the bottle code." |
| Incomplete outcome data (attrition bias) | High risk | Comment: a total of 39 (15.2%) infants were lost to follow‐up with similar distribution in both the groups. Reasons for loss to follow‐up not given |
| Selective reporting (reporting bias) | High risk | Comment: methods describe that the clinicians did physical examinations and recorded weight, nutritional status, any signs of vitamin A deficiency, heart rate, respiratory rate, temperature, and systemic examination, especially neurological examination including the state of the fontanelle, reflexes, motor and sensory functions, etc. But bulging fontanelle not reported as an outcome, nor other variables mentioned in the results |
| Other bias | Low risk | Comment: no other apparent bias |