| Study characteristics |
| Methods |
Single‐centre, randomised, single‐blind clinical study |
| Participants |
Children aged 1.5 to 5 years with first simple FS, weight and height above the third percentile, and normal serum zinc level |
| Interventions |
Group 1: Daily zinc sulfate 2 mg/kg (maximum 50 mg) for 6 consecutive months
Group 2: Placebo |
| Outcomes |
Seizure recurrence at 12 months, side effects |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Low risk |
Computer‐generated equal simple randomisation |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Single‐blind design |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No loss to follow‐up, no exclusions |
| Selective reporting (reporting bias) |
High risk |
Recurrence data at 3, 6, and 9 months not given. Kaplan‐Meier method used to report results, no absolute numbers. |
| Other bias |
Low risk |
No bias identified. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Randomisation and blinding were done by an investigator with no clinical involvement in the trial. Data collectors, outcome assessors, and data analysts were all kept blinded to the allocation. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Randomisation and blinding were done by an investigator with no clinical involvement in the trial. Data collectors, outcome assessors, and data analysts were all kept blinded to the allocation. |
