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Pharmacodynamics of Oral Cholecalciferol in Healthy Individuals with Vitamin D Deficiency: A Randomized Open-Label Study
- Source :
- Nutrients, Nutrients, Vol 13, Iss 2293, p 2293 (2021), Volume 13, Issue 7
- Publication Year :
- 2021
- Publisher :
- MDPI AG, 2021.
-
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 &lt<br />20 ng/mL) receiving oral cholecalciferol with three different dosing regimens: Group A: 10,000 IU/day for 8 weeks followed by 1000 IU/day for 4 weeks<br />Group B: 50,000 IU/week for 12 weeks and Group C: 100,000 IU every other week for 12 weeks. Regulators of calcium and phosphate homeostasis, bone turnover markers and Wnt inhibitors were measured at baseline, Day 28, 53, 84, and 112. The 1,25OH2D increased at each time point. The increase was greater (p &lt<br />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.
- Subjects :
- Adult
Male
0301 basic medicine
medicine.medical_specialty
Osteoporosis
Healthy Individuals
vitamin D
030209 endocrinology & metabolism
Article
vitamin D deficiency
Phosphates
Bone remodeling
03 medical and health sciences
chemistry.chemical_compound
0302 clinical medicine
Internal medicine
pharmacodynamics
medicine
Vitamin D and neurology
Humans
Pharmacokinetics
TX341-641
Dosing
Cholecalciferol
Nutrition and Dietetics
Nutrition. Foods and food supply
business.industry
Vitamins
Middle Aged
Vitamin D Deficiency
medicine.disease
osteoporosis
Vitamin D, Pharmacokinetics, Healthy Individuals
Healthy Volunteers
Fibroblast Growth Factor-23
030104 developmental biology
Endocrinology
chemistry
Pharmacodynamics
supplementation
Sclerostin
Calcium
Female
Bone Remodeling
business
bone turnover markers
Biomarkers
Food Science
Subjects
Details
- ISSN :
- 20726643
- Volume :
- 13
- Database :
- OpenAIRE
- Journal :
- Nutrients
- Accession number :
- edsair.doi.dedup.....980964f741962abcfcb4dc77906a4013