Drury 2008.
Study characteristics | ||
Methods | RCT. Parallel design. Duration: 1 month. Location: Montreal Children's Hospital Cystic Fibrosis Clinic, Canada. Date not specified. |
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Participants | Randomised: n = 14; 8 to 18 years, gender unspecified. Inclusion criteria
Exclusion criteria
Withdrawal or loss to follow‐up: missing data (1) from 5 mg group at final assessment. |
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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
Measured at the beginning of the trial and at the end of 1 month. |
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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. |