Kuitert 2010.
Study characteristics | ||
Methods | RCT. Parallel. Duration: 12 months. Location: CF clinics at Barts and the London, Kings College Hospital and Lewisham University NHS Trusts, UK. |
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Participants | Participants with a diagnosis of CF (positive sweat test or genotype testing) aged over 16 years (post pubertal‐stage IV Tanner), either sex, pancreatic insufficient (i.e. with a positive faecal elastase test, and requiring pancreatic enzyme supplementation), no overt liver disease and not taking vitamin K. 38 participants recruited. Age: 16 ‐ 43 years. |
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Interventions |
Intervention: 10 mg of menadiol phosphate (water soluble form of vitamin K) once daily orally. Control: placebo. |
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Outcomes |
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Notes | Trial was undertaken at CF clinics at Barts and the London, Kings College Hospital and Lewisham University NHS Trusts, UK. The trial details could only be obtained as an abstract of poster presentation of conference proceedings or entries on trials registries. An electronic mail communication with the trial author could not obtain any further information. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Described as randomised, but no further details given in the published abstract. |
Allocation concealment (selection bias) | Unclear risk | Details not available/published in the abstract. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Details not available/published, although the abstract describes the control as "placebo". |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Details not available/published. |
Selective reporting (reporting bias) | Unclear risk | Protocol available on trial registry websites, but limited results only published in abstract form and not a full paper. |
Other bias | Unclear risk | Insufficient detail available to make a judgement. |
ALT: alanine aminotransferase AST: aspartate aminotransferase BMI: body mass index CF: cystic fibrosis IU: international units NCHS: National Center for Health Statistics PIVKA‐II: proteins induced by vitamin K absence or antagonism factor II RCT: randomised controlled trial