{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T01:12:34Z","timestamp":1760058754188,"version":"build-2065373602"},"reference-count":26,"publisher":"MDPI AG","issue":"9","license":[{"start":{"date-parts":[[2025,4,25]],"date-time":"2025-04-25T00:00:00Z","timestamp":1745539200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"FAES FARMA S.A.","award":["HIDR-0320\/DR"],"award-info":[{"award-number":["HIDR-0320\/DR"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>Background\/Objectives: Adequate vitamin D levels are critical for overall health, yet vitamin D deficiency remains prevalent. This study aims to evaluate the efficacy and safety of a standardized weekly supplementation regimen of 100 \u03bcg calcifediol for patients with varying degrees of vitamin D deficiency. Methods: A post hoc pool analysis was conducted from a randomized, double-blind, placebo-controlled, multicenter, two-cohort trial. Cohort 1 included vitamin D mild deficiency patients (25(OH)D levels &gt; 10 &lt; 20 ng\/mL) and Cohort 2 severe deficiency patients (25(OH)D levels \u2264 10 ng\/mL). As both had placebo and weekly calcifediol 100 \u03bcg arms (ratio 1:2), a pooled analysis of safety and efficacy was conducted. The primary outcome was the percentage of subjects achieving 25(OH)D levels \u2265 20 ng\/mL and\/or \u226530 ng\/mL at various time points. Results: A total of 401 participants across both cohorts were included in the analysis, 130 who received a placebo and 271 calcifediol 100 \u00b5g weekly. By week 52, 94.5% of individuals in the calcifediol group achieved 25(OH)D levels \u2265 20 ng\/mL, compared to 25.3% in the placebo group (p &lt; 0.0001). At this same week, 80.5% of subjects in the calcifediol group, but none in the placebo group (p &lt; 0.0001), had 25(OH)D levels \u2265 30 ng\/mL. The mean 25(OH)D level plateaued around 40.7 ng\/mL from weeks 16 to 52. The frequency of treatment-emergent adverse events was similar in both groups, placebo and calcifediol. Conclusions: Weekly supplementation of 100 \u03bcg calcifediol effectively restores vitamin D levels in individuals with both mild and severe deficiencies, demonstrating a favourable safety profile.<\/jats:p>","DOI":"10.3390\/jcm14092976","type":"journal-article","created":{"date-parts":[[2025,4,25]],"date-time":"2025-04-25T08:02:57Z","timestamp":1745568177000},"page":"2976","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Analysis of the Efficacy and Safety of Weekly Calcifediol 100 \u00b5g in Vitamin D Deficient Patients"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1723-217X","authenticated-orcid":false,"given":"Jose Luis","family":"P\u00e9rez Castrill\u00f3n","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, R\u00edo Hortega University Hospital, 47012 Valladolid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1234-8560","authenticated-orcid":false,"given":"Esteban","family":"J\u00f3dar-Gimeno","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Nutrition, Quir\u00f3nsalud Madrid University Hospital, 28223 Madrid, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koldobika","family":"Molina","sequence":"additional","affiliation":[{"name":"Clinical Research Department, FAES FARMA, 48940 Leioa, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aintzane","family":"Garc\u00eda-Bea","sequence":"additional","affiliation":[{"name":"Medical Affairs Department, FAES FARMA, 48940 Leioa, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cristina Mart\u00ednez","family":"Ostal\u00e9","sequence":"additional","affiliation":[{"name":"Clinical Research Department, FAES FARMA, 48940 Leioa, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Inmaculada","family":"Gilaberte","sequence":"additional","affiliation":[{"name":"Clinical Research Department, FAES FARMA, 48940 Leioa, Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,4,25]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","unstructured":"Grant, W.B., Wimalawansa, S.J., Pludowski, P., and Cheng, R.Z. 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