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Fast responses to Vitamin D – loading dose, nanoemulsion and Calcifediol – April 2023


Responses: Loading dose <4 days. nanoemulsion <1 day?, Calcifediol xx? days

Long-Term Treatment and Effect of Discontinuation of Calcifediol in Postmenopausal Women with Vitamin D Deficiency: A Randomized Trial

J Bone Miner Res . 2023 Apr;38(4):471-479. doi: 10.1002/jbmr.4776. Epub 2023 Feb 13.
José Luis Pérez-Castrillón 1 2, Antonio Dueñas-Laita 2 3, Carlos Gómez-Alonso 4, Esteban Jódar 5 6, Javier Del Pino-Montes 7 8, Maria Luisa Brandi 9, Fernando Cereto Castro 10, José Manuel Quesada-Gómez 11 12, Laura Gallego López 13, José Manuel Olmos Martínez 14 15 16, María Rosa Alhambra Expósito 11 12, Bernat Galarraga 17 18, Jesús González-Macías 15 16, José Luis Neyro 19 20, Roger Bouillon 21, Gonzalo Hernández-Herrero 22, Nieves Fernández-Hernando 22, Sandra P Chinchilla 22

Response 90 days?
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Note: Higher response to D expected if had given 35,000 monthly or 12,500 bi-weekly

Half-Life
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Vitamin D plays a major role in bone health and probably also in multiple extraskeletal acute and chronic diseases. Although supplementation with calcifediol, a vitamin D metabolite, has demonstrated efficacy and safety in short-term clinical trials, its effects after long-term monthly administration have been studied less extensively. This report describes the results of a 1-year, phase III-IV, double-blind, randomized, controlled, parallel, multicenter superiority clinical trial to assess the efficacy and safety of monthly calcifediol 0.266 mg versus cholecalciferol 25,000 IU (0.625 mg) in postmenopausal women with vitamin D deficiency (25(OH)D < 20 ng/mL).
A total of 303 women were randomized and 298 evaluated. Patients were randomized 1:1:1 to

  • calcifediol 0.266 mg/month for 12 months (Group A1 ),
  • calcifediol 0.266 mg/month for 4 months followed by placebo for 8 months (Group A2 ), and
  • cholecalciferol 25,000 IU/month (0.625 mg/month) for 12 months (Group B ).

By month 4, stable 25(OH)D levels were documented with both calcifediol and cholecalciferol (intention-to-treat population): 26.8 ± 8.5 ng/mL (Group A1 ) and 23.1 ± 5.4 ng/mL (Group B ). By month 12, 25(OH)D levels were 23.9 ± 8.0 ng/mL (Group A1 ) and 22.4 ± 5.5 ng/mL (Group B ). When calcifediol treatment was withdrawn in Group A2, 25(OH)D levels decreased to baseline levels (28.5 ± 8.7 ng/mL at month 4 versus 14.4 ± 6.0 ng/mL at month 12). No relevant treatment-related safety issues were reported in any of the groups. The results confirm that long-term treatment with monthly calcifediol in vitamin D-deficient patients is effective and safe. The withdrawal of treatment leads to a pronounced decrease of 25(OH)D levels. Calcifediol presented a faster onset of action compared to monthly cholecalciferol. Long-term treatment produces stable and sustained 25(OH)D concentrations with no associated safety concerns. © 2023 Faes Farma SA. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
 Download the PDF from VitaminDWiki


VitaminDWiki – Calcidiol (calcifediol) contains

46 items in Calcidiol category

Calcidiol = Calcifediol = 25-hydroxyvitamin D3 = 25(OH)D = semi-activated Vitamin D
See also

Attached files

ID Name Comment Uploaded Size Downloads
19467 half life.jpg admin 15 Apr, 2023 45.71 Kb 104
19466 Calciferol.jpg admin 15 Apr, 2023 37.90 Kb 115
19465 Calcifediol on and off RCT_CompressPdf.pdf admin 15 Apr, 2023 369.98 Kb 95