drugset / Trial / NCT05591170
Effect of Single High Dose of Cholecalciferol on Serum Metabolites of Vitamin D
RandomizedParallel-groupOpen-labelDiagnostic
Summary
The aim of this interventional study is to assess the effect of the single high dose of vitamin D on its serum metabolites in elderly. The main questions it attempts to answer is: 1. what is the effect of a single, high, oral dose of vitamin D3 (120,000 IU) on serum 25(OH)D3, 25(OH)D2, 24,25(OH)2D3, 3-epi-25(OH)D3, 1,25(OH)2D3, 24,25(OH)2D3/25(OH)D3 ratio, and 25(OH)D3/3-epi-25(OH)D3 ratio concentration at baseline, 3 days and 7 days after administration, compared to control group. 2. what is the influence of percentage of fat tissue on serum metabolites of vitamin D and their changes after bolus dose, compared to control group.
Timeline
- Start
- 2021-04-01
- Primary completion
- 2021-08-31
- Completion
- 2021-08-31
Publications
- Background Ilahi M, Armas LA, Heaney RP. Pharmacokinetics of a single, large dose of cholecalciferol. Am J Clin Nutr. 2008 Mar;87(3):688-91. doi: 10.1093/ajcn/87.3.688.
- Background Saleh L, Tang J, Gawinecka J, Boesch L, Fraser WD, von Eckardstein A, Nowak A. Impact of a single oral dose of 100,000 IU vitamin D3 on profiles of serum 25(OH)D3 and its metabolites 24,25(OH)2D3, 3-epi-25(OH)D3, and 1,25(OH)2D3 in adults with vitamin D insufficiency. Clin Chem Lab Med. 2017 Oct 26;55(12):1912-1921. doi: 10.1515/cclm-2016-1129.
- Leszczynska D, Szatko A, Kowalski K, Raczkiewicz D, Ostrowska M, Misiorowski W, Zgliczynski W, Glinicki P. The Effect of a Single High Dose of Vitamin D on Serum Levels of Its Metabolites in the Elderly. Front Biosci (Landmark Ed). 2022 Oct 25;27(10):289. doi: 10.31083/j.fbl2710289.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cholecalciferol | Other / unclassified | 120000 iu | Oral |