Methods |
Randomised controlled cross‐over trial. |
Participants |
14 children (7 females, 7 males) with heterozygous FH, mean age 9.1 +/‐ 1.1 years. |
Interventions |
Rapeseed oil margarine with or without sitostanol ester for 6 weeks in addition to low fat, low cholesterol diet. |
Outcomes |
Total, VLDL, HDL & LDL cholesterol, phospholipids & triglycerides & apolipoprotein E. |
Notes |
NB. Short‐term outcomes only will be assessed. |
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. |
Selective reporting (reporting bias) |
Low risk |
All the outcomes stated in methods were reported |