| Methods |
Design: three group parallel trial
Purpose: study the risk of vomiting and regurgitation in children with diarrhoea treated with Zink or placebo |
| Participants |
Patients: children with diarrhoea (short stay ward or outpatient clinic)
Baseline comparability: yes |
| Interventions |
Placebo: dispersible tablet without Zink
Untreated: no tablet
Experimental: dispersible tablet with Zink
(Co‐intervention: standard treatment for diarrhoea) |
| Outcomes |
Proportion of patients that vomit
Proportion of patients that regurgitatee |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Low risk |
'numbered' and 'opaque envelopes' |
| Blinding?
Treatment provider |
Low risk |
'This randomized, double‐blind, placebo‐controlled clinical trial...' |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| Trial size > 49? |
Low risk |
N =1066 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
Low risk |
All three categories fulfilled |
