Funded in part by Abiogen Pharma
Pharmacodynamics of Oral Cholecalciferol in Healthy Individuals with Vitamin D Deficiency: A Randomized Open-Label Study
Fassio A, Gatti D, Rossini M, Benini C, Fracassi E, Bertoldo E, Viapiana O, Milleri S, Gatti M, Adami G
Nutrients · 5 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
- Company
- Abiogen Pharma
- Authors
- At least one author declares a financial tie to industry
Based on 1 listed funder(s) and full-text disclosure statement.
Publication
- Published
- 2021-07-02 · Nutrients · vol. 13 · issue 7 · p. 2293
- Publisher
- Multidisciplinary Digital Publishing Institute
- Cited
- 9 citations · more than 63% of similar papers · 0.6× the field average
- References
- 51 works
- Access
- Open access (journal) · CC-BY
- Research areas
- Vitamin D Research Studies · Adrenal Hormones and Disorders · Thyroid Disorders and Treatments
- Keywords
- Cholecalciferol, Medicine, Vitamin D and neurology, Internal medicine, Parathyroid hormone, Endocrinology, vitamin D deficiency, Dosing, Pharmacodynamics, Bone remodeling, Vitamin, Calcium, Pharmacokinetics
- MeSH
- humans, vitamin d deficiency, phosphates, calcium, cholecalciferol, vitamins, bone remodeling, adult, middle aged, female, male, healthy volunteers, biomarkers, fibroblast growth factor-23
10 authors
From IT
- Angelo Fassio · correspondingUniversity of Verona
- Davide Gatti · correspondingUniversity of Verona
- Maurizio RossiniUniversity of Verona
- Camilla BeniniUniversity of Verona
- Elena FracassiUniversity of Verona
- Eugenia BertoldoUniversity of Verona
Abstract
Comparative pharmacodynamic (PD) analyses on different dosing schedules for cholecalciferol supplementation are limited. This was an open-label, randomized, parallel-group study involving 75 healthy individuals deficient in vitamin D (baseline 25OHD p < 0.05) for group A vs. B and C at Day 28, and vs. group B at Day 56. No significant difference among groups was observed for the other biomarkers. The 24,25OH2D remained stable over time. PTH decreased at Day 84 and FGF-23 increased at all time points. CTX-I and PINP increased slightly at Day 28. BALP decreased from Day 56 onward. Dkk-1 increased from Day 56 onward, while sclerostin did not show significant changes. In healthy individuals deficient in vitamin D, vitamin D supplementation exerted effects on multiple regulators of calcium, phosphate and bone metabolism, without marked differences using the three regimens.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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