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A Randomized Phase II/III Trial Evaluating the Efficacy and Safety of 100 and 125 μg of Calcifediol Weekly Treatment of Severe Vitamin D Deficiency

JL. Pérez-Castrillón, E. Jódar-Gimeno, J. Nociar, M. Lojka, D. Nikolov, F. Cereto-Castro, S. Novković, U. Tarantino, N. Mehsen-Cetre, P. Arranz, C. Martínez Ostalé, A. García-Bea, I. Gilaberte

. 2025 ; 17 (4) : . [pub] 20250213

Language English Country Switzerland

Document type Journal Article, Randomized Controlled Trial, Clinical Trial, Phase II, Multicenter Study, Clinical Trial, Phase III

Persistent link   https://www.medvik.cz/link/bmc25009880

Grant support
2020-001099-14 Faes Farma (Spain)

Background/Objectives: Given the crucial health benefits of vitamin D, addressing severe deficiencies is a pressing medical concern. This study aimed to evaluate the effectiveness and safety of two new weekly doses of calcifediol (100 μg and 125 μg) for long-term management in patients with severe vitamin D deficiency, defined as plasma 25(OH)D levels ≤10 ng/mL. Methods: This study was a randomized, two-cohort, controlled, double-blind, multicentre phase II-III trial. Subjects were randomized 2:2:1 to weekly calcifediol 100 μg, 125 μg or a placebo. The primary endpoint was the proportion of patients achieving plasma 25(OH)D levels of ≥20 ng/mL and/or ≥30 ng/mL by week 16. Results: A total of 276 patients (mean age: 55.2 years, SD 15.42) were randomized. By week 16, 92.3% and 91.8% of patients in the calcifediol 100 μg and 125 μg groups, respectively, reached ≥20 ng/mL, compared to 7.3% in the placebo group. Levels of ≥30 ng/mL were achieved by 49% (100 μg) and 76.4% (125 μg) of participants, with none in the placebo group. Calcifediol demonstrated superior efficacy at all response levels and time points (p < 0.0001). Plasma 25(OH)D concentrations increased by week 24 and remained stable. The incidence of adverse events was comparable across groups. Conclusions: A weekly calcifediol dose of 100 μg demonstrates the best profile of efficacy and tolerability, providing a reliable solution for achieving and maintaining adequate vitamin D levels in patients with severe deficiency.

References provided by Crossref.org

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$a Background/Objectives: Given the crucial health benefits of vitamin D, addressing severe deficiencies is a pressing medical concern. This study aimed to evaluate the effectiveness and safety of two new weekly doses of calcifediol (100 μg and 125 μg) for long-term management in patients with severe vitamin D deficiency, defined as plasma 25(OH)D levels ≤10 ng/mL. Methods: This study was a randomized, two-cohort, controlled, double-blind, multicentre phase II-III trial. Subjects were randomized 2:2:1 to weekly calcifediol 100 μg, 125 μg or a placebo. The primary endpoint was the proportion of patients achieving plasma 25(OH)D levels of ≥20 ng/mL and/or ≥30 ng/mL by week 16. Results: A total of 276 patients (mean age: 55.2 years, SD 15.42) were randomized. By week 16, 92.3% and 91.8% of patients in the calcifediol 100 μg and 125 μg groups, respectively, reached ≥20 ng/mL, compared to 7.3% in the placebo group. Levels of ≥30 ng/mL were achieved by 49% (100 μg) and 76.4% (125 μg) of participants, with none in the placebo group. Calcifediol demonstrated superior efficacy at all response levels and time points (p < 0.0001). Plasma 25(OH)D concentrations increased by week 24 and remained stable. The incidence of adverse events was comparable across groups. Conclusions: A weekly calcifediol dose of 100 μg demonstrates the best profile of efficacy and tolerability, providing a reliable solution for achieving and maintaining adequate vitamin D levels in patients with severe deficiency.
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$a Jódar-Gimeno, Esteban $u Department of Endocrinology and Nutrition, Quirón Madrid University Hospital, Universidad Europea, 28670 Madrid, Spain $1 https://orcid.org/0000000212348560
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$a Nociar, Ján $u Department of Cardiology, General Hospital with Polyclinic Lučenec n.o., 98401 Lučenec, Slovakia
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$a Nikolov, Dimitar $u Department of Rheumatology, Medical Center-1-Sevlievo, 5400 Sevlievo, Bulgaria
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$a Arranz, Paula $u Clinical Research Department, FAES FARMA, 48940 Leioa, Spain
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