Pant 1996.
| Study characteristics | ||
| Methods | Cluster‐randomised trial in rural Nepal | |
| Participants |
Eligibility: children aged 6 months to 10 years Sample: from 100 potentially eligible cluster sites, 75 were randomised (approximately 25,301 children). Baseline data on the number in each treatment group, proportion of boys and mean age not provided |
|
| Interventions | 3 intervention groups Experimental group I: single‐dose vitamin A 100,000 IU for children aged 6–12 months and 200,000 IU for children aged 1–10 years via a capsule Control group I: control (not adequately described) Control group II: nutritional education Study duration: 24 months |
|
| Outcomes | All‐cause mortality and Bitot's spots | |
| Notes | No details on loss to follow‐up were given. Inclusion/exclusion criteria were inadequately described. No nominators/denominators were available for Bitot's spots. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "Using random number tables and the reference number for each block …". |
| Allocation concealment (selection bias) | Unclear risk | Comment: insufficient detail provided to make a judgement. |
| Blinding (performance bias and detection bias) Blinding of participants | Unclear risk | Comment: insufficient detail provided to make a judgement. |
| Blinding (performance bias and detection bias) Blinding of provider | Unclear risk | Comment: insufficient detail provided to make a judgement. |
| Blinding (performance bias and detection bias) Blinding of outcome assessor | Unclear risk | Comment: insufficient detail provided to make a judgement. |
| Incomplete outcome data (attrition bias) | High risk | Comment: no information given as regards how incomplete outcome data were addressed. |
| Selective reporting (reporting bias) | High risk | Comment: very specific outcomes reported. 5 types of examinations were administered to the children: ophthalmic, physical, anthropometric, blood and faecal; however, data in results were given only for prevalence of Bitot's spots and all‐cause mortality |
| Other bias | Unclear risk | Comment: insufficient detail provided to make a judgement. |