@article{10902/24461,
year = {2021},
url = {http://hdl.handle.net/10902/24461},
abstract = {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.},
publisher = {John Wiley & Sons},
publisher = {J Bone Miner Res
. 2021 Oct;36(10):1967-1978},
title = {Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial},
author = {Pérez-Castrillón, José Luis and Dueñas-Laita, Antonio and Brandi, Maria Luisa and Jódar, Esteban and Del Pino-Montes, Javier and Quesada-Gómez, José Manuel and Cereto Castro, Fernando and Gómez-Alonso, Carlos and Gallego López, Laura and Olmos Martínez, José Manuel and Alhambra Expósito, María Rosa and Galarraga, Bernat and González Macías, Jesús and Bouillon, Roger and Hernández-Herrero, Gonzalo and Fernández-Hernando, Nieves and Arranz-Gutiérrez, Paula and Chinchilla, Sandra P},
}