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Nutrients
Volume 12
Issue 6
10.3390/nu12061553
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Article

Pharmacokinetics of Oral Cholecalciferol in Healthy Subjects with Vitamin D Deficiency: A Randomized Open-Label Study

by
Angelo Fassio
1,*,
Giovanni Adami
1,
Maurizio Rossini
1,
Alessandro Giollo
1,
Cristian Caimmi
1,
Riccardo Bixio
1,
Ombretta Viapiana
1,
Stefano Milleri
2,
Matteo Gatti
1 and
Davide Gatti
1
1
Rheumatology Unit, University of Verona, 37131 Verona, Italy
2
Centro Ricerche Cliniche di Verona SRL, 37131 Verona, Italy
*
Author to whom correspondence should be addressed.
Nutrients 2020, 12(6), 1553; https://doi.org/10.3390/nu12061553
Received: 12 May 2020 / Revised: 20 May 2020 / Accepted: 25 May 2020 / Published: 27 May 2020
(This article belongs to the Section Micronutrients and Human Health)
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Abstract

Background: The aim of this study was to investigate the pharmacokinetic (PK) and safety profile of high-dose vitamin D supplementation, comparing different schedules (daily, weekly, or bi-weekly) in an otherwise healthy vitamin D-deficient population. Methods: Single-center, open-label study on healthy subjects deficient in vitamin D (25 (OH)D < 20 ng/mL), randomized to receive cholecalciferol (DIBASE®, Abiogen Pharma, Italy) using three different schedules: Group A: 10,000 IU/day for eight weeks followed by 1000 IU/day for four weeks; Group B: 50,000 IU/week for 12 weeks, Group C: 100,000 IU/every other week for 12 weeks. Total cumulative doses were: 588,000 IU, 600,000 IU, 600,000 IU. The treatment regimens corresponded to the highest doses allowed for cholecalciferol for the correction of vitamin D deficiency in adults in Italy. Results: mean 25 (OH)D plasma levels significantly increased from baseline 13.5 ± 3.7 ng/mL to peak values of 81.0 ± 15.0 ng/mL in Group A, 63.6 ± 7.9 ng/mL in Group B and 59.4 ± 12 ng/mL in Group C. On day 28, all subjects showed 25 (OH)D levels ≥20 ng/mL and 93.1% had 25 (OH)D levels ≥30 ng/mL. On day 56 and 84, all subjects had 25 (OH)D levels ≥30 ng/mL. No serious adverse events occurred during the study. Conclusions: normalization of 25 (OH)D serum levels was quickly attained with all the studied regimens. A more refracted schedule provided a higher systemic 25 (OH)D exposure. View Full-Text
Keywords: vitamin D; cholecalciferol; osteoporosis; osteomalacia; supplementation vitamin D; cholecalciferol; osteoporosis; osteomalacia; supplementation
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MDPI and ACS Style

Fassio, A.; Adami, G.; Rossini, M.; Giollo, A.; Caimmi, C.; Bixio, R.; Viapiana, O.; Milleri, S.; Gatti, M.; Gatti, D. Pharmacokinetics of Oral Cholecalciferol in Healthy Subjects with Vitamin D Deficiency: A Randomized Open-Label Study. Nutrients 2020, 12, 1553. https://doi.org/10.3390/nu12061553

AMA Style

Fassio A, Adami G, Rossini M, Giollo A, Caimmi C, Bixio R, Viapiana O, Milleri S, Gatti M, Gatti D. Pharmacokinetics of Oral Cholecalciferol in Healthy Subjects with Vitamin D Deficiency: A Randomized Open-Label Study. Nutrients. 2020; 12(6):1553. https://doi.org/10.3390/nu12061553

Chicago/Turabian Style

Fassio, Angelo, Giovanni Adami, Maurizio Rossini, Alessandro Giollo, Cristian Caimmi, Riccardo Bixio, Ombretta Viapiana, Stefano Milleri, Matteo Gatti, and Davide Gatti. 2020. "Pharmacokinetics of Oral Cholecalciferol in Healthy Subjects with Vitamin D Deficiency: A Randomized Open-Label Study" Nutrients 12, no. 6: 1553. https://doi.org/10.3390/nu12061553

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