Funded in part by Bruno Farmaceutici S.p.A., Faes Farma S.A.
Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial
Pérez-Castrillón JL, Dueñas-Laita A, Brandi ML, Jódar E, Del Pino-Montes J, Quesada-Gómez JM, Cereto Castro F, Gómez-Alonso C, Gallego López L, Olmos Martínez JM, Alhambra Expósito MR, Galarraga B, González-Macías J, Bouillon R, Hernández-Herrero G, Fernández-Hernando N, Arranz-Gutiérrez P, Chinchilla SP
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research · 43 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Industry funded
- Company
- Bruno Farmaceutici S.p.A.
- Company
- Faes Farma S.A.
- Authors
- At least one author declares a financial tie to industry
Based on 2 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2020-12-01 · J Bone Miner Res · vol. 36 · issue 10 · pp. 1967–1978
- Publisher
- Oxford University Press
- Cited
- 58 citations · more than 96% of similar papers · 4.8× the field average
- Impact
- Top 10% most cited in its field
- References
- 54 works
- Access
- Open access (hybrid journal) · CC-BY-NC-ND
- Research areas
- Vitamin D Research Studies · Bone health and osteoporosis research · Parathyroid Disorders and Treatments
- Keywords
- Calcifediol, Cholecalciferol, Medicine, Vitamin D and neurology, Internal medicine, vitamin D deficiency, Calcitriol, Quality of Life Research, Randomized controlled trial, Population, Placebo, Vitamin, Gastroenterology, Endocrinology, Pathology, Public health
- MeSH
- humans, vitamin d deficiency, cholecalciferol, calcifediol, vitamin d, double-blind method, postmenopause, dietary supplements, female
18 authors
From ES, IT, BE
- José Luis Pérez‐CastrillónUniversidad de Valladolid; Hospital Universitario Río Hortega
- Antonio Dueñas‐LaitaUniversidad de Valladolid; Hospital Universitario Río Hortega
- Maria Luisa BrandiUniversity of Florence
- Esteban JódarHospital Universitario Quirónsalud Madrid; IDCQ Hospitales y Sanidad, S.L.U.; Universidad Europea de Madrid
- Javier del Pino‐MontesUniversidad de Salamanca; Complejo Hospitalario de Salamanca
- José Manuel Quesada‐GómezInstituto Maimónides de Investigación Biomédica de Córdoba; Hospital Universitario Reina Sofía
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).
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY-NC-ND).
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