Study design (if review, criteria of inclusion for studies)
Randomized, placebo-controlled, double-blind study. Parallel design.
49 children attending the Fibrocystic Clinic at Babies Hospital (Columbia-Presbyterian Medical Center, New York) randomised. Diagnostic criteria not stated. Paper states " Only patients with a proven diagnosis of cystic fibrosis, and who were apparently stabilized on an accepted regimen of therapy, were accepted for the study." Patients had not previously received supplementary tocopherol.See note on withdrawals below, for final analysis 45 patients followed for at least 2 months, 37 patients completed 6 months of trial (18 in tocopherol group; 19 in placebo group).
2 or 3 divided doses of 0.2 ml of mixture/kg/day.Supplement:10 mg/dl alpha-tocopheryl acetate/kg/day.Placebo: further details not given.
Weight, muscle strength, blood tests (tocopherol level; S-GOT), subjective rating of disease severity (scale of 1 - 5) by outcome assessors, estimate in change of disease status (scale 0 - 6) by outcome assessors after discussions with patients/carers.