TY - JOUR 
A1 - Pérez Castrillón, José Luis
AU - Dueñas Laita, Antonio
AU - Brandi, María Luisa
AU - Jódar Gimeno, José Esteban
AU - Pino Montes, Javier del
AU - Quesada Gómez, José Manuel
AU - Cereto Castro, Fernando
AU - Gómez Alonso, Carlos
AU - Gallego López, Laura
AU - Chinchilla Gallo, Sandra Pamela
AU - Et al.
T1 - Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial
Y1 - 2021
SN - 0884-0431

UR - http://hdl.handle.net/11268/11368
AB - Vitamin D has shown to play a role in multiple diseases due to its skeletal and extraskeletal actions. Furthermore, vitamin D deficiency has become a worldwide health issue. Few supplementation guidelines mention calcifediol treatment, despite being the direct precursor of calcitriol and the biomarker of vitamin D status. This 1-year, phase III-IV, double-blind, randomized, controlled, multicenter clinical trial assessed the efficacy and safety of calcifediol 0.266 mg soft capsules in vitamin D-deficient postmenopausal women, compared to cholecalciferol. Results reported here are from a prespecified interim analysis, for the evaluation of the study's primary endpoint: the percentage of patients with serum 25-hydroxyvitamin D (25(OH)D) levels above 30 ng/ml after 4 months. A total of 303 patients were enrolled, of whom 298 were included in the intention-to-treat (ITT) population. Patients with baseline levels of serum 25(OH)D <20 ng/ml were randomized 1:1:1 to calcifediol 0.266 mg/month for 12 months, calcifediol 0.266 mg/month for 4 months followed by placebo for 8 months, and cholecalciferol 25,000 IU/month for 12 months. At month 4, 35.0% of postmenopausal women treated with calcifediol and 8.2% of those treated with cholecalciferol reached serum 25(OH)D levels above 30 ng/ml (p < 0.0001). The most remarkable difference between both drugs in terms of mean change in serum 25(OH)D levels was observed after the first month of treatment (mean ± standard deviation change = 9.7 ± 6.7 and 5.1 ± 3.5 ng/ml in patients treated with calcifediol and cholecalciferol, respectively). No relevant treatment-related safety issues were reported in any of the groups studied. These results thus confirm that calcifediol is effective, faster, and more potent than cholecalciferol in raising serum 25(OH)D levels and is a valuable option for the treatment of vitamin D deficiency.
KW - Menopausia
KW - Deficiencia de vitamina D
KW - Colecalciferol
KW - Salud de la mujer
KW - Vitamina
KW - Efectos fisiológicos
LA - eng
ER -