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Article

Efficacy and Safety of Calcifediol in Young Adults with Vitamin D Deficiency: A Phase I, Multicentre, Clinical Trial—POSCAL Study

by
Pedro Guerra López
1,
Mikel Urroz Elizalde
1,2,
Noelia Vega-Gil
3,
Blanca Sánchez Santiago
3,
Iñaki Zorrilla Martínez
4,5,6,7,8,
Mario Jiménez-Mercado
4,
Esteban Jódar
9,10,
Araitz Landeta Manzano
11,
Cristina Campo Hoyos
11,* and
Jesús Frías Iniesta
1,2
1
Clinical Trials Unit, Pharmacology Department, Universidad Autónoma de Madrid, 28049 Madrid, Spain
2
Clinical Pharmacology Service, Hospital Universitario La Paz, 28049 Madrid, Spain
3
Valdecilla Clinical Trials Unit, Hospital Universitario Marqués de Valdecilla-IDIVAL, 39008 Santander, Spain
4
Clinical Trials Unit, IIS BIOARABA, 01009 Vitoria-Gasteiz, Spain
5
Mental Health and Childhood Research Group, IIS BIOARABA, 01009 Vitoria-Gasteiz, Spain
6
Psychiatry Department, Araba University Hospital, 01009 Vitoria-Gasteiz, Spain
7
Department of Neurosciences, University of the Basque Country UPV/EHU, 01006 Vitoria-Gasteiz, Spain
8
CIBER of Mental Health (CIBERSAM), Institute of Health Carlos III, 28029 Madrid, Spain
9
Department of Endocrinology and Nutrition, Quirónsalud Madrid University Hospital, 28233 Madrid, Spain
10
School of Health Sciences, European University of Madrid, 28670 Madrid, Spain
11
Medical Affairs, FAES FARMA S.A., 48940 Leioa, Spain
 
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Author to whom correspondence should be addressed.
Nutrients 2024, 16(2), 306; https://doi.org/10.3390/nu16020306
Submission received: 22 December 2023 / Revised: 12 January 2024 / Accepted: 14 January 2024 / Published: 19 January 2024
(This article belongs to the Section Micronutrients and Human Health)
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Abstract

Vitamin D deficiency is highly prevalent, and recent evidence suggests a possible association between vitamin D deficiency and various health conditions. The aim of this study was to assess monthly calcifediol treatments for vitamin D deficiency (or biweekly, if the deficiency was severe) in a young adult population with no associated comorbidities. This multicentre phase I trial started with a four month open-label treatment phase (TP) that included 101 participants (65% women with mean age 29.8 years). Eighty-two percent of the subjects (79/96) achieved 25(OH)D levels within the target range (20–60 ng/mL) by the end of the TP, and they were subsequently randomised and subjected to a double-blind, placebo-controlled, five month follow-up phase (FP). At the end of the FP, 89% of participants maintained vitamin D levels of >20 ng/mL with calcifediol, versus 49% with placebo (p < 0.001). Subjects receiving monthly calcifediol during both phases (n = 32) maintained 25(OH)D levels >20 ng/mL, whereas those on the placebo during the FP (n = 38) exhibited deficiency levels of 25(OH)D by the end of the study. No clinically relevant changes in bone metabolism parameters or toxic 25(OH)D levels were observed, and no serious adverse events were reported throughout the study. Calcifediol is a safe and effective treatment for vitamin D deficiency in the young adult population, but long-term use may be required to sustain optimal 25(OH)D levels.
Keywords: 25-hydroxyvitamin D3; calcifediol; clinical trial; vitamin D deficiency; young adults 25-hydroxyvitamin D3; calcifediol; clinical trial; vitamin D deficiency; young adults

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MDPI and ACS Style

Guerra López, P.; Urroz Elizalde, M.; Vega-Gil, N.; Sánchez Santiago, B.; Zorrilla Martínez, I.; Jiménez-Mercado, M.; Jódar, E.; Landeta Manzano, A.; Campo Hoyos, C.; Frías Iniesta, J. Efficacy and Safety of Calcifediol in Young Adults with Vitamin D Deficiency: A Phase I, Multicentre, Clinical Trial—POSCAL Study. Nutrients 2024, 16, 306. https://doi.org/10.3390/nu16020306

AMA Style

Guerra López P, Urroz Elizalde M, Vega-Gil N, Sánchez Santiago B, Zorrilla Martínez I, Jiménez-Mercado M, Jódar E, Landeta Manzano A, Campo Hoyos C, Frías Iniesta J. Efficacy and Safety of Calcifediol in Young Adults with Vitamin D Deficiency: A Phase I, Multicentre, Clinical Trial—POSCAL Study. Nutrients. 2024; 16(2):306. https://doi.org/10.3390/nu16020306

Chicago/Turabian Style

Guerra López, Pedro, Mikel Urroz Elizalde, Noelia Vega-Gil, Blanca Sánchez Santiago, Iñaki Zorrilla Martínez, Mario Jiménez-Mercado, Esteban Jódar, Araitz Landeta Manzano, Cristina Campo Hoyos, and Jesús Frías Iniesta. 2024. "Efficacy and Safety of Calcifediol in Young Adults with Vitamin D Deficiency: A Phase I, Multicentre, Clinical Trial—POSCAL Study" Nutrients 16, no. 2: 306. https://doi.org/10.3390/nu16020306

APA Style

Guerra López, P., Urroz Elizalde, M., Vega-Gil, N., Sánchez Santiago, B., Zorrilla Martínez, I., Jiménez-Mercado, M., Jódar, E., Landeta Manzano, A., Campo Hoyos, C., & Frías Iniesta, J. (2024). Efficacy and Safety of Calcifediol in Young Adults with Vitamin D Deficiency: A Phase I, Multicentre, Clinical Trial—POSCAL Study. Nutrients, 16(2), 306. https://doi.org/10.3390/nu16020306

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