RT info:eu-repo/semantics/article
T1 Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial
A1 Pérez Castrillon, José Luis
K1 Endocrinologia y Metabolismo
K1 CALCIFEDIOL; CHOLECALCIFEROL; VITAMIN D DEFICIENCY; MENOPAUSE; CLINICAL TRIALS
AB ABSTRACTVitamin 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 for4 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 Wiley
SN 0884-0431
YR 2021
FD 2021
LK https://uvadoc.uva.es/handle/10324/64702
UL https://uvadoc.uva.es/handle/10324/64702
LA eng
NO Journal Bone and Mineral Research 2021; 36 ( October ): 1967-1978
NO Producción Científica
DS UVaDOC
RD 13-may-2024