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. 2017 Mar 6;2017(3):CD009422. doi: 10.1002/14651858.CD009422.pub3

Harries 1969.

Methods Randomised controlled study of parallel design with 3 arms.
Single‐centre study in UK.
Duration 1 month.
Participants 30 children with CF on pancreatic enzyme supplementation. Age range 6 months to 14.5 years.
Interventions Acute supplementation and long‐term supplementation.
Children received either:

  • no supplementation;

  • water‐miscible preparation of vitamin E at a dose of 10 mg/kg;

  • fat‐soluble vitamin E at a dose of 10 mg/kg.
Outcomes Serum vitamin E levels and serum RBC haemolysis.
Notes Acute supplementation (called oral load test in the paper) was only done in 2 participants without controls.
The study does not clarify whether the participants were pancreatic sufficient or insufficient.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not clearly specified in the the paper, states "chosen at random and arbitrarily assigned to one of three groups".
Allocation concealment (selection bias) Unclear risk Not clearly specified in the the paper.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Not clearly specified in the the paper. Very likely not blinded, as 1 of arms was no treatment. Objective outcome is measured so absence of blinding unlikely to increase risk of bias.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Not clearly specified in the the paper. Objective outcome is measured so absence of blinding unlikely to increase risk of bias.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk At 1 month reported data for 9 out of 10 participants in fat‐soluble group (i.e. 1 dropout) and for 8 out of 10 participants in water miscible group (i.e. 2 dropouts), no discussions of reasons for dropouts. However, these missing data are unlikely to have a significant impact on the results.
Selective reporting (reporting bias) Unclear risk Trial protocol not available, but outcomes stated in 'Methods' section reported in 'Results'.
Other bias Unclear risk Limited information the basis of diagnosis of CF, pancreatic sufficiency/insufficiency etc.