Methods |
Randomised, controlled, cross‐over trial. |
Participants |
Pediatric patients with hypercholesterolaemia with a subgroup of 16 patients who had FH. |
Interventions |
Low fat diet with plant stanol spread compared with low fat diet with sterol ester spread for 5 weeks; separated by a 5‐week washout period. |
Outcomes |
Total, VLDL, HDL & LDL cholesterol, triglycerides, Apo‐B and non‐cholesterol sterols. |
Notes |
NB: Only short term outcomes were assessed, data for the 17 patients with FH not available. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Stated 'randomised' but method not described. |
Allocation concealment (selection bias) |
Unclear risk |
Unclear. |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Described as double‐blind, but not stated who was blinded. |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Intention‐to‐treat analysis was considered adequate. No dropouts. |
Selective reporting (reporting bias) |
Low risk |
No reporting bias was noted |