Santosham 1985.

Methods	Randomized controlled trial
Participants	Number: 89 enrolled Inclusion criteria: 0 to 12 months with acute watery diarrhoea (<7 days duration, at least 5 watery stools per day)
Interventions	1. Soy‐based lactose‐free formula 4 hrs after hospitalization: 43 participants 2. Food was withheld for the first 48 hours of hospitalization: 44 participants
Outcomes	Stool output in the first 24 and 48 hours and during illness (ml/kg); percentage weight gain on the following: 24th and 48th hour, resolution of illness and two weeks after discharge; duration of diarrhoea (hrs); serum sodium and potassium on admission, during and at resolution of illness
Setting	Hospital based trial Location: Indian Health Service Hospital, Whiteriver, Arizona, USA
Notes	One person in each group was excluded because food other than that allowed for the study was taken Persistent vomiting was defined as more than 3 times in an 8 hour interval necessitating intravenous therapy Persistent diarrhoea defined as more than 7 days of diarrhoea
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Randomly assigned using block randomization of groups of four
Allocation concealment (selection bias)	Unclear risk	No details given in trial report
Blinding (performance bias and detection bias) All outcomes	High risk	Participants were not blinded, but it was unclear if the caregivers or the outcome assessors were blinded
Incomplete outcome data (attrition bias) All outcomes	Low risk	43 out of 44 and 44 out of 45 patients in the early and late refeeding group, respectively, were included in the final analysis
Selective reporting (reporting bias)	Unclear risk	No details given in trial report
Other bias	Unclear risk	No details given in trial report