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Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial
Author(s) -
PérezCastrillón José Luis,
DueñasLaita Antonio,
Brandi Maria Luisa,
Jódar Esteban,
del PinoMontes Javier,
QuesadaGómez José Manuel,
Cereto Castro Fernando,
GómezAlonso Carlos,
Gallego López Laura,
Olmos Martínez José Manuel,
Alhambra Expósito María Rosa,
Galarraga Bernat,
GonzálezMacías Jesús,
Bouillon Roger,
HernándezHerrero Gonzalo,
FernándezHernando Nieves,
ArranzGutiérrez Paula,
Chinchilla Sandra P.
Publication year - 2021
Publication title -
journal of bone and mineral research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.882
H-Index - 241
eISSN - 1523-4681
pISSN - 0884-0431
DOI - 10.1002/jbmr.4387
Subject(s) - calcifediol , cholecalciferol , medicine , vitamin d and neurology , vitamin d deficiency , calcitriol , quality of life research , randomized controlled trial , population , placebo , vitamin , gastroenterology , endocrinology , pathology , public health , alternative medicine , environmental health
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. © 2021 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).