Cherian 2001.
Study characteristics | ||
Methods | Individually randomised trial conducted in India | |
Participants |
Eligibility: children aged 12–60 months with recurrent respiratory tract infections Excluded: children with mild or moderate asthma; who were receiving vitamin supplements or who had received a massive dose of vitamin A in the previous 6 months; with pre‐existing congenital heart disease, chronic lung disease, pulmonary tuberculosis or immunodeficiency disorders; receiving immunosuppressive drugs; with clinically apparent VAD Sample: 61 children; 30 in vitamin A group, 31 in placebo group. Mean age 35.7 months. 60.7% boys |
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Interventions |
Experimental group: single‐dose vitamin A 200,000 IU Control group: placebo in arachis oil Follow‐up: 6 months |
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Outcomes | Incidence of respiratory disease, mean vitamin A serum levels | |
Notes | Definition of respiratory illness used was not specific enough. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: "Eligible children were randomly allocated to receive either 200,000 IU of vitamin A in arachis oil or a placebo containing arachis oil without vitamin A". Comment: details of sequence generation not specified. |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information to permit judgement. |
Blinding (performance bias and detection bias) Blinding of participants | Unclear risk | Quote: "Eligible children were randomly allocated to receive either 200,000 IU of vitamin A in arachis oil or a placebo containing arachis oil without vitamin A". |
Blinding (performance bias and detection bias) Blinding of provider | Unclear risk | Comment: not mentioned. |
Blinding (performance bias and detection bias) Blinding of outcome assessor | Unclear risk | Comment: not mentioned. |
Incomplete outcome data (attrition bias) | Unclear risk |
Quote: "Of the 61 included children, seven (3 in the placebo group and four in vitamin A group) did not return for follow‐up" (second page). Comment: authors did not address the reasons for losses to follow‐up, and given the small size of this trial, bias may or may not be introduced depending on why the losses occurred by group. Given this lack of discussion, it is difficult to judge whether there is a low or high risk of bias, but it is likely to be high. |
Selective reporting (reporting bias) | Unclear risk |
Quote: "Details of doctor or outpatient visits and hospital cough, wheezy breathing, shortness of breath and fever. Details of doctor or outpatient visits and hospital admissions during the study period were also recorded. During each monthly follow‐up visit, the entries in the monthly calendar were reviewed with the parent". Comment: hospitalisation data were not reported though they were collected. |
Other bias | Unclear risk | Comment: very little information provided in the paper; difficult to assess. |