Weekly Calcifediol 100 µg in Women with Vitamin D Deficiency: A Post Hoc Analysis of a Randomised Placebo-Controlled Phase II/III Trial
5 affiliations
- 1Department of Internal Medicine, Río Hortega University Hospital, 47012 Valladolid, Spain
- 2Department of Endocrinology and Nutrition, Quirónsalud Madrid University Hospital, 28223 Madrid, Spain
- 3Department of Medicine, Faculty of Medicine, Health and Sports, Universidad Europea de Madrid, 28670 Villaviciosa de Odón, Spain
- 4Medical Affairs Department, FAES FARMA, 48940 Leioa, Spain
- 5Clinical Development Department, FAES FARMA, 48940 Leioa, Spain
Abstract
Background/Objective: Given the high prevalence of vitamin D deficiency, particularly among older women, this post hoc analysis was conducted to evaluate the long-term efficacy and safety of weekly calcifediol 100 µg in women with vitamin D deficiency participating in a randomised, double-blind, phase II/III trial. Methods: A total of 261 women were included (calcifediol, n = 192; placebo, n = 69). The primary objective was to compare the proportions of women achieving serum 25(OH)D concentrations ≥20 ng/mL or ≥30 ng/mL over the 12-month treatment period. Exploratory analyses of body mass index (BMI) and menopausal status were performed. Results: Weekly calcifediol 100 µg demonstrated superior efficacy versus placebo from week 4 in women achieving ≥20 ng/mL (68.2% vs. 5.8%; p < 0.001) or ≥30 ng/mL (21.4% vs. 0%; p < 0.001), and consistently higher proportions were maintained through week 52. Mean 25(OH)D concentrations increased from 12.21 ng/mL at baseline to 39.47 ng/mL at week 16, and remained stable (41–43 ng/mL) thereafter. No significant differences were observed across BMI or menopausal status subgroups. The safety profile of weekly calcifediol 100 µg was similar to placebo, with no evidence of toxicity. Conclusions: Weekly calcifediol 100 µg is a safe and effective option for achieving and maintaining adequate vitamin D levels in vitamin D-deficient women over a period of 12 months, and is associated with consistent effects across BMI and menopausal status.
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BibTeX
@article{castrillon2026weekly,
title = {{Weekly Calcifediol 100 µg in Women with Vitamin D Deficiency: A Post Hoc Analysis of a Randomised Placebo-Controlled Phase II/III Trial}},
author = {José Luis Pérez Castrillón and Esteban Jódar-Gimeno and Aintzane García-Bea and Cristina Martínez Ostalé and Inmaculada Gilaberte},
journal = {Nutrients},
year = {2026},
month = nov,
doi = {10.3390/nu18213658},
url = {https://www.mdpi.com/2072-6643/18/21/3658},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Weekly Calcifediol 100 µg in Women with Vitamin D Deficiency: A Post Hoc Analysis of a Randomised Placebo-Controlled Phase II/III Trial
AU - José Luis Pérez Castrillón
AU - Esteban Jódar-Gimeno
AU - Aintzane García-Bea
AU - Cristina Martínez Ostalé
AU - Inmaculada Gilaberte
PY - 2026
DA - 2026/11/04
JO - Nutrients
DO - 10.3390/nu18213658
UR - https://www.mdpi.com/2072-6643/18/21/3658
AB - Background/Objective: Given the high prevalence of vitamin D deficiency, particularly among older women, this post hoc analysis was conducted to evaluate the long-term efficacy and safety of weekly calcifediol 100 µg in women with vitamin D deficiency participating in a randomised, double-blind, phase II/III trial. Methods: A total of 261 women were included (calcifediol, n = 192; placebo, n = 69). The primary objective was to compare the proportions of women achieving serum 25(OH)D concentrations ≥20 ng/mL or ≥30 ng/mL over the 12-month treatment period. Exploratory analyses of body mass index (BMI) and menopausal status were performed. Results: Weekly calcifediol 100 µg demonstrated superior efficacy versus placebo from week 4 in women achieving ≥20 ng/mL (68.2% vs. 5.8%; p < 0.001) or ≥30 ng/mL (21.4% vs. 0%; p < 0.001), and consistently higher proportions were maintained through week 52. Mean 25(OH)D concentrations increased from 12.21 ng/mL at baseline to 39.47 ng/mL at week 16, and remained stable (41–43 ng/mL) thereafter. No significant differences were observed across BMI or menopausal status subgroups. The safety profile of weekly calcifediol 100 µg was similar to placebo, with no evidence of toxicity. Conclusions: Weekly calcifediol 100 µg is a safe and effective option for achieving and maintaining adequate vitamin D levels in vitamin D-deficient women over a period of 12 months, and is associated with consistent effects across BMI and menopausal status.
SN - 2072-6643
ER -