Pharmacokinetics of Oral Cholecalciferol in Healthy Subjects with Vitamin D Deficiency: A Randomized Open-Label Study
Fassio A, Adami G, Rossini M, Giollo A, Caimmi C, Bixio R, Viapiana O, Milleri S, Gatti M, Gatti D
Nutrients · 41 citations
Review labels
Neutral facts our review recorded about how this study was done. They describe method, never whether we like the result.
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Industry funded
- University or hospital
- Università degli Studi di Verona
- Authors
- At least one author declares a financial tie to industry
Based on 1 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2020-05-27 · Nutrients · vol. 12 · issue 6 · p. 1553
- Publisher
- Multidisciplinary Digital Publishing Institute
- Cited
- 55 citations · more than 95% of similar papers · 4.0× the field average
- Impact
- Top 10% most cited in its field
- References
- 34 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Vitamin D Research Studies · Vitamin K Research Studies · Biotin and Related Studies
- Keywords
- Cholecalciferol, Pharmacokinetics, Vitamin D and neurology, Open label, Medicine, vitamin D deficiency, Vitamin, Randomized controlled trial, Internal medicine
- MeSH
- humans, osteomalacia, osteoporosis, vitamin d deficiency, phosphates, calcium, cholecalciferol, vitamin d, serum albumin, dietary supplements, adolescent, adult, middle aged, italy, female, male, young adult, healthy volunteers
10 authors
From IT
- Angelo Fassio · correspondingUniversity of Verona
- Giovanni AdamiUniversity of Verona
- Maurizio RossiniUniversity of Verona
- Alessandro GiolloUniversity of Verona
- Cristian CaimmiUniversity of Verona
- Riccardo BixioUniversity of Verona
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 ®, 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.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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