Overview
Vitamin D, in general, is a secosteroid generated in the skin when 7-dehydrocholesterol located there interacts with ultraviolet irradiation - like that commonly found in sunlight . Both the endogenous form of vitamin D (that results from 7-dehydrocholesterol transformation), vitamin D3 (cholecalciferol), and the plant-derived form, vitamin D2 (ergocalciferol), are considered the main forms of vitamin d and are found in various types of food for daily intake . Structurally, ergocalciferol differs from cholecalciferol in that it possesses a double bond between C22 and C23 and has an additional methyl group at C24 . Finally, ergocalciferol is pharmacologically less potent than cholecalciferol, which makes vitamin D3 the preferred agent for medical use . Appropriate levels of vitamin D must be upheld in the body in order to maintain calcium and phosphorus levels in a healthy physiologic range to sustain a variety of metabolic functions, transcription regulation, and bone metabolism . However, studies are also ongoing to determine whether or not cholecalciferol may also play certain roles in cancer, autoimmune disorders, cardiovascular disease, and other medical conditions that may be associated with vitamin D deficiency .
Background
Vitamin D, in general, is a secosteroid generated in the skin when 7-dehydrocholesterol located there interacts with ultraviolet irradiation - like that commonly found in sunlight . Both the endogenous form of vitamin D (that results from 7-dehydrocholesterol transformation), vitamin D3 (cholecalciferol), and the plant-derived form, vitamin D2 (ergocalciferol), are considered the main forms of vitamin d and are found in various types of food for daily intake . Structurally, ergocalciferol differs from cholecalciferol in that it possesses a double bond between C22 and C23 and has an additional methyl group at C24 . Finally, ergocalciferol is pharmacologically less potent than cholecalciferol, which makes vitamin D3 the preferred agent for medical use . Appropriate levels of vitamin D must be upheld in the body in order to maintain calcium and phosphorus levels in a healthy physiologic range to sustain a variety of metabolic functions, transcription regulation, and bone metabolism . However, studies are also ongoing to determine whether or not cholecalciferol may also play certain roles in cancer, autoimmune disorders, cardiovascular disease, and other medical conditions that may be associated with vitamin D deficiency .
Indication
Cholecalciferol use is indicated for the treatment of specific medical conditions like refractory rickets (or vitamin D resistant rickets), hypoparathyroidism, and familial hypophosphatemia . Concurrently, as one of the most commonly utilized forms of vitamin D, cholecalciferol is also very frequently used as a supplement in individuals to maintain sufficient vitamin d levels in the body or to treat vitamin D deficiency, as well as various medical conditions that can be associated directly or indirectly with vitamin d insufficiency like osteoporosis and chronic kidney disease, among others .
Associated Conditions
- Bone Fractures
- Calcium and Vitamin D Deficiencies
- Deficiency of Vitamin D3
- Deficiency, Vitamin A
- Deficiency, Vitamin D
- Hip Fracture
- Hypoparathyroidism
- Hypophosphatemia, Familial
- Menopause
- Osteomalacia
- Osteoporosis
- Postmenopausal Osteoporosis
- Vertebral Fractures
- Vitamin D Resistant Rickets
- Vitamin Deficiency
- Severe Bone Resorption
- Spine fracture
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2012/11/09 | Not Applicable | Completed | |||
2012/10/17 | Phase 4 | Completed | |||
2012/09/27 | Not Applicable | Completed | |||
2012/09/21 | Phase 3 | Completed | |||
2012/08/16 | Not Applicable | Completed | |||
2012/08/02 | Phase 2 | Completed | |||
2012/07/20 | Phase 3 | Completed | |||
2012/07/13 | Not Applicable | Withdrawn | |||
2012/07/11 | Phase 2 | UNKNOWN | |||
2012/07/03 | Phase 4 | UNKNOWN |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
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No FDA approvals found for this drug. |
EMA Drug Approvals
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HSA Drug Approvals
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NMPA Drug Approvals
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PPB Drug Approvals
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TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Nature's Way Kids Smart Bursts Calcium + Vitamin D3 | 315760 | Pharmacare Laboratories Pty Ltd | Medicine | A | 3/26/2019 |
AusNatures Kids Vitamin D3 Liquid | 314185 | Medicine | A | 2/13/2019 | |
Biostime Immune Defence + Lactoferrin | 338934 | Medicine | A | 7/4/2020 | |
Charmant Koala Kids Chewable Multivitamin Tablet | 276091 | Medicine | A | 6/1/2016 | |
Imunor Forte | 334283 | Medicine | A | 4/15/2020 | |
Oriental Botanicals Kids' Nutrient Ninja | 405981 | Medicine | A | 3/8/2023 | |
Eagle Joint Ease | 405976 | Medicine | A | 3/8/2023 | |
Swisse Multivitamin with B Vitamins | 371585 | Medicine | A | 7/23/2021 | |
Cognisense Pro | 407896 | Medicine | A | 4/19/2023 | |
Nature’s Way Kids Smart High Strength Vita Gummies Vitamin D3 500 IU | 407893 | Pharmacare Laboratories Pty Ltd | Medicine | A | 4/19/2023 |