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. 2020 Jun 4;2020(6):CD008482. doi: 10.1002/14651858.CD008482.pub6

Drury 2008.

Study characteristics
Methods RCT.
Parallel design.
Duration: 1 month.
Location: Montreal Children's Hospital Cystic Fibrosis Clinic, Canada.
Date not specified.
Participants Randomised: n = 14; 8 to 18 years, gender unspecified.
Inclusion criteria
  • CF with pancreatic insufficiency; method of CF diagnosis unreported


Exclusion criteria
  • known liver disease (diagnosed by ultrasound, liver function tests and/or hepatomegaly)

  • supplemental therapeutic vitamin K to treat coagulopathies


Withdrawal or loss to follow‐up: missing data (1) from 5 mg group at final assessment. 
Interventions Intervention: oral administration of injectable formulation of vitamin K1 phytonadione (Sandoz Canada, Boucherville, Qc) diluted 1 mg/1 mL; dose 1 mg/day for 1 month.
Control: oral administration of injectable formulation of vitamin K1 phytonadione (Sandoz Canada, Boucherville, Qc) diluted 1 mg/1 mL; dose 5 mg/day for 1 month.
Outcomes Primary outcomes: none reported
Secondary outcomes
  • plasma vitamin K1 levels

  • serum undercarboxylated osteocalcin levels


Measured at the beginning of the trial and at the end of 1 month.
Notes This project was funded by the Canadian CF Foundation.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "were randomised to receive either 1 mg/day, or 5 mg/day" Page 458.
Comment: insufficient information to make a clear judgement of 'Yes' or 'No'.
Allocation concealment (selection bias) Unclear risk Not reported.
Probably not done.
Blinding (performance bias and detection bias)
All outcomes Unclear risk Participants: not reported.
Healthcare providers: unclear.
Outcomes assessors and data analysts: unclear.
Comment: overall judgement unclear.
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote "One subject in the 5 mg group lost consciousness at the time of the second blood procurement". Page 458.
Comment: incomplete data for one participant.
Selective reporting (reporting bias) Low risk The stated objectives of the trial appear to match the listed outcomes. There was no evidence of selective reporting of outcomes.
Other bias Unclear risk Quote: "This project was funded by the Canadian CF Foundation".
Comment: it is unclear to what extent the support provided may have had on the results of this trial. Insufficient information to assess whether an important risk of bias exists.