Study design (if review, criteria of inclusion for studies)
Randomised control trial over 1-month period. Montreal Children's Hospital Cystic Fibrosis Clinic, Canada. Date not specified.
Participants
N = 14; 8 to 18 years, gender unspecified. Inclusion criteria CF with pancreatic insufficiency. Method of CF diagnosis unreported known liver disease (diagnosed by ultrasound, liver function tests and/or hepatomegaly) Exclusion criteria: supplemental therapeutic vitamin K to treat coagulopathies Withdrawal or loss to follow-up: missing data (1) from 5 mg group at final assessment.
Interventions
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: identical but dose 5 mg/day for 1 month.
Outcome measures
Primary outcomes: none reported Secondary outcomes plasma vitamin K1 levels Measured at the beginning of the trial and at the end of 1 month. serum undercarboxylated osteocalcin levels
Main results
Of the 50% of subjects who were below the optimal serum vitamin K1 at baseline, all rose into the normal range with supplementation. Supplementation also significantly reduced the overall %Glu-OC from a median of 46.8 to 29.1% (p<0.0003).
Authors' conclusions
Both 1 mg and 5 mg of vitamin K1, given over a one-month period in pancreatic insufficient pediatric cystic fibrosis patients improve vitamin K status.