| Methods |
Randomised controlled cross‐over trial. |
| Participants |
41 children with confirmed or suspected FH (mean age 10.5 years +/‐ 1.7 years). Three dropped out (2 because of family problems and one because she found the amount of spread was too large |
| Interventions |
Plant sterol‐enriched fat spread (8 weeks) versus a control spread not enriched with plant sterols (8 weeks). 4‐week washout period. |
| Outcomes |
Total, LDL, HDL cholesterol, triacylglycerol, apolipoprotein A1 and B, carotenoids, retinol and alpha‐tocopherol concentrations, and albumin and other blood biochemistry. |
| Notes |
3 children were withdrawn from the trial and not followed up. |
| 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 |
High risk |
3 participants were withdrawn from the trials and not included in the final analysis. 2 girls dropped out during the trial because of family problems not related to the project, and a third because she found that the amount of spread was too large. |
| Selective reporting (reporting bias) |
Low risk |
All the outcomes stated in methods were reported. |
