RT Journal Article
T1 Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial.
A1 Perez-Castrillón, Jose Luis
A1 Dueñas-Laita, Antonio
A1 Brandi, Maria Luisa
A1 Jodar, Esteban
A1 Del Pino-Montes, Javier
A1 Quesada-Gomez, Jose Manuel
A1 Cereto Castro, Fernando
A1 Gomez-Alonso, Carlos
A1 Gallego Lopez, Laura
A1 Olmos Martinez, Jose Manuel
A1 Alhambra Exposito, Maria Rosa
A1 Galarraga, Bernat
A1 Gonzalez-Macias, Jesus
A1 Bouillon, Roger
A1 Hernandez-Herrero, Gonzalo
A1 Fernandez-Hernando, Nieves
A1 Arranz-Gutierrez, Paula
A1 Chinchilla, Sandra P
K1 Calcifediol
K1 Cholecalciferol
K1 Clinical trials
K1 Menopause
K1 Vitamin D deficiency
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 primaryendpoint: 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.
PB Oxford University Press
YR 2021
FD 2021-06-24
LK http://hdl.handle.net/10668/17975
UL http://hdl.handle.net/10668/17975
LA en
NO Pérez-Castrillón JL, Dueñas-Laita A, Brandi ML, Jódar E, Del Pino-Montes J, Quesada-Gómez JM, et al. Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial. J Bone Miner Res. 2021 Oct;36(10):1967-1978
DS RISalud
RD Apr 7, 2025