Evidence map›Paper›PMID 34101900›Full record

Trial reportJournal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research2021

Calcifediol is superior to cholecalciferol in improving vitamin D status in postmenopausal women: a randomized trial.

José Luis Pérez-Castrillón, Antonio Dueñas-Laita, Maria Luisa Brandi, Esteban Jódar, Javier Del Pino-Montes, José Manuel Quesada-Gómez, Fernando Cereto Castro, Carlos Gómez-Alonso, Laura Gallego López, José Manuel Olmos Martínez and 8 more

Erratum issuedOpen access · greenAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 37 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 5 pooled it
5.2field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 5 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Too much vitamin D? a drug safety review.Reviews in endocrine & metabolic disorders · 2026
    Review
  11. Review
  12. Article
  13. Article
  14. The role of nutritional vitamin D in chronic kidney disease-mineral and bone disorder in children and adults with chronic kidney disease, on dialysis, and after kidney transplantation-a European consensus statement.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2025
    Article
  15. Observational
  16. Vitamin D: are all compounds equal?Clinical kidney journal · 2025
    Article
  17. Article
  18. Selective Oxidation of Vitamin DChemistry (Weinheim an der Bergstrasse, Germany) · 2024
    Article
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 11 institutions in 3 countries.

José Luis Pérez-CastrillónInternal Medicine Department, Hospital Universitario Río Hortega, Valladolid, Spain.
Antonio Dueñas-LaitaSchool of Medicine, Universidad de Valladolid, Valladolid, Spain.
Maria Luisa BrandiDipartimento di Scienze Biomediche, Sperimentali e Cliniche "Mario Serio", Università degli Studi di Firenze, Florence, Italy.ORCID 0000-0002-8741-0592
Esteban JódarDepartment of Endocrinology & Clinical Nutrition, Hospital Universitario Universitario Quironsalud Madrid, Madrid, Spain.
Javier Del Pino-MontesSchool of Medicine, Universidad de Salamanca, Salamanca, Spain.
José Manuel Quesada-GómezInstituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.
Fernando Cereto CastroInternal Medicine Department, Hospital Quirón Barcelona, Barcelona, Spain.
Carlos Gómez-AlonsoBone Metabolism Unit, Hospital Universitario Central de Asturias - ISPA, Oviedo, Spain.
Laura Gallego LópezHospital Universitario Virgen Macarena, Sevilla, Spain.
José Manuel Olmos MartínezInternal Medicine Department, Hospital Universitario Marqués de Valdecilla - IDIVAL, Santander, Spain.
María Rosa Alhambra ExpósitoInstituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Córdoba, Spain.
Bernat GalarragaRheumatology Department, Hospital Quirónsalud Bizkaia, Erandio, Spain.
Jesús González-MacíasSchool of Medicine, Universidad de Cantabria, Santander, Spain.
Roger BouillonDepartment of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.ORCID 0000-0002-6446-3763
Gonzalo Hernández-HerreroR&D and Innovation Department, Faes Farma, Leioa, Spain.
Nieves Fernández-HernandoR&D and Innovation Department, Faes Farma, Leioa, Spain.
Paula Arranz-GutiérrezR&D and Innovation Department, Faes Farma, Leioa, Spain.
Sandra P ChinchillaR&D and Innovation Department, Faes Farma, Leioa, Spain.ORCID 0000-0003-4304-0996
Faes Farma (Spain) · ESHospital Quirónsalud Barcelona · ESInstituto Maimónides de Investigación Biomédica de Córdoba · ESUniversidad de Cantabria · ESUniversidad de Valladolid · ESHospital Universitario Central de Asturias · ESHospital Universitario Quirónsalud Madrid · ESHospital Universitario Virgen Macarena · ESKU Leuven · BEUniversidad de Salamanca · ESUniversity of Florence · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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).

Indexed as

CalcifediolVitamin D DeficiencyCholecalciferolDietary SupplementsDouble-Blind MethodFemaleHumansPostmenopauseVitamin DCalcifediolCholecalciferolVitamin DCALCIFEDIOLCHOLECALCIFEROLCLINICAL TRIALSMENOPAUSEVITAMIN D DEFICIENCY

Identifiers

PMID34101900
PMCPMC8597097
OpenAlexW3169297761

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.