Study design (if review, criteria of inclusion for studies)
double-blind, randomized, placebo controlled, cross-over trial
Participants
22 CF patients (12.9+/-2.5 yrs) with predominantly mild lung disease.
Interventions
mixture of multiple micronutrients (ML1)
Outcome measures
Anthropometric measures, pulmonary function, exercise performance by bicycle ergometry, muscular strength and vitamins A and E were determined.
Main results
Analysis was performed using the paired Student t-test comparing the change in each parameter during ML1 and placebo. Plasma vitamin E and A levels increased during ML1 when compared to placebo. However, no significant difference between the effect of the ML1 or placebo was observed neither for FEV1, FVC, anthropometry, nor for the parameters for muscle performance.
Authors' conclusions
The micronutrient mixture was not superior to placebo with respect to changes in pulmonary function or muscle performance in pediatric CF patients, despite a significant increase in plasma vitamin E concentrations.