Seguridad y eficacia de una nueva pauta de suplementación en pacientes con fibrosis quística e insuficiencia de vitamina D

Abstract

ObjectivesBased on the European and American cystic fibrosis (CF) consensus recommendations, an increase in vitamin D (VD) supplementation in patients with CF and insufficient or deficient levels was proposed. The objective of our study was to determine the safety and efficacy of this new protocol. Material and methodsMulticentre nonrandomized uncontrolled experimental study. Patients with insufficient levels (<30ng/mL) received increasing doses of VD (between 800 and 10,000IU/day). Patients were followed up for 12 months, during which their vitamin and nutritional status, pulmonary function and calcium and phosphate metabolism were assessed. Statistical analysis: t test for paired data and multivariate logistic regression analysis. ResultsThirty patients aged 1–39 years (median, 9.1) completed the follow-up. Two patients were dropped from the study on account of 25-OH VD levels greater than 100ng/mL at 3 months without clinical or laboratory signs of hypercalcaemia. At 12 months, we observed an increase of 7.6ng/mL (95% CI, 4.6–10ng/mL) in the mean 25-OH VD level and an improvement in vitamin status: 37% achieved levels of 30ng/mL or greater, 50% levels between 20 and 30ng/mL and 13% remained with levels of less than 20ng/mL. We found no association between improved VD levels and pulmonary function. ConclusionsThe proposed protocol achieved an increase in serum VD levels and a decrease in the percentage of patients with VD insufficiency, although it was still far from reaching the percentages of sufficiency recommended for this entity.