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. 2017 Aug 22;2017(8):CD008482. doi: 10.1002/14651858.CD008482.pub5

Beker 1997.

Methods Randomised cross‐over trial (2 periods of 4 weeks).
 CF Clinic Children's National Medical Center (CNMC), Washington DC.
 No date specified.
Participants Randomised: N = 18 (8 male, 10 female); mean age 20 years (range 13 ‐ 35 years).
Inclusion criteria
  • confirmed diagnosis of CF by duplicate sweat test

  • clinically stable as determined by physical exam; afebrile

  • moderate lung disease based on an average radiograph score of 15 using the Brasfield scoring method

  • within or above the fifth NCHS height percentile for age and body mass index (BMI) ≥20

  • AST/ALT levels within the normal range, and normal plasma albumin levels


Exclusion criteria
  • without cholestasis or overt liver disease

  • elevated AST/ALT


Withdrawal or loss to follow‐up: none reported.
Interventions Intervention: 5 mg oral vitamin K1 supplementation per week.
Control: no supplementation.
4 weeks of first treatment then crossed over to the other treatment for a second 4‐week period.
Concomitant medications permitted: cephalosporin (13); sulfamethoxazole (3); erythromycin (1); bronchodilators; standard multivitamins and 200 ‐ 400 IU vitamin E.
Outcomes Primary outcomes: none reported
Secondary outcomes (assessments at entry and end of each trial period)
  • plasma vitamin K1 and vitamin K1‐2,3 epoxide

  • plasma PIVKA‐II

  • serum osteocalcin


3‐day dietary intake records were completed during each treatment period, but these did not correspond with the nutritional parameters sought as secondary outcomes for this review.
Patient compliance was verified by the trial coordinator at each visit.
Notes Randomised cross‐over trial, vitamin K supplementation compared with no treatment. No wash‐out period with a potential carry‐over of treatment effect. No first‐period data available.
"Supported in part by grants from the Board of Lady Visitors, Children's National Medical Center, Washington, DC, and the University of Maryland, College Park, Maryland."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomly assigned" Page 512
 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 possible; control was 'no treatment'.
Healthcare providers: not possible; control was 'no treatment'.
Outcomes assessors and data analysts: unclear.
Comment: overall judgement unclear.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk There were no withdrawals and no missing or incomplete data.
Selective reporting (reporting bias) Low risk Although the protocol was not available all relevant outcomes appear to have been addressed.
Other bias Unclear risk Quote: "Supported in part by grants from the Board of Lady Visitors, Children's National Medical Center, Washington, DC, and the University of Maryland, College Park, Maryland."
 Comment: it is unclear to what extent the support provided may have had on the results of this study. Insufficient information to assess whether an important risk of bias exists.