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 .
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
Research Report
A Comprehensive Monograph on Cholecalciferol (Vitamin D3): From Molecular Structure to Clinical Application
Executive Summary
Cholecalciferol, commonly known as Vitamin D3, is a fat-soluble secosteroid that functions as a critical prohormone within the human body. While historically classified as a vitamin, its endogenous synthesis in the skin upon exposure to sunlight and its subsequent multi-organ activation into a potent hormone underscore its central role in a complex endocrine system. The primary and undisputed function of the Vitamin D system is the maintenance of calcium and phosphate homeostasis, which is essential for normal bone mineralization. Consequently, Cholecalciferol is a cornerstone therapy for the prevention and treatment of a range of skeletal disorders arising from its deficiency, including rickets in children, osteomalacia in adults, and as an adjunct with calcium for osteoporosis management.
A significant body of scientific evidence has established the clinical superiority of Cholecalciferol (D3) over its plant-derived counterpart, Ergocalciferol (D2). Studies consistently demonstrate that D3 is more potent and has a longer duration of action in raising and sustaining serum concentrations of 25-hydroxyvitamin D, the key indicator of vitamin D status. This has led to a broad consensus that Cholecalciferol should be the preferred form for both supplementation and therapeutic repletion.
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2022/11/14 | Phase 3 | Recruiting | |||
2022/10/26 | Phase 1 | Recruiting | |||
2022/10/24 | Phase 4 | Completed | Department of Endocrinology, Centre of Postgraduate Medical Education | ||
2022/10/13 | Phase 2 | Completed | |||
2022/09/29 | Not Applicable | Completed | |||
2022/09/23 | Phase 1 | Not yet recruiting | Yangzhou University | ||
2022/07/15 | Phase 2 | Completed | |||
2022/07/11 | Not Applicable | Completed | |||
2022/06/24 | Phase 2 | Completed | Saiful Anwar Hospital | ||
2022/06/24 | Phase 4 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Cameron Pharmaceuticals | 42494-433 | ORAL | 10 ug in 1 1 | 9/18/2023 | |
PureTek Corporation | 59088-166 | ORAL | 20 ug in 1 1 | 2/8/2023 | |
Sandoz Inc | 54643-7874 | INTRAVENOUS | 200 [iU] in 10 mL | 10/28/2016 | |
Everett Laboratories, Inc. | 0642-0070 | ORAL | 25 ug in 1 1 | 9/1/2021 | |
Sandoz Inc | 54643-5650 | INTRAVENOUS | 200 [iU] in 10 mL | 3/17/2016 | |
PureTek Corporation | 59088-180 | ORAL | 13.75 ug in 1 1 | 1/11/2023 | |
PureTek Corporation | 59088-018 | ORAL | 10 ug in 1 1 | 5/15/2025 | |
H.J. Harkins Company, Inc. | 52959-593 | ORAL | 400 [iU] in 1 mL | 10/25/2011 | |
PureTek Corporation | 59088-187 | ORAL | 20 ug in 1 1 | 1/11/2023 | |
Bryant Ranch Prepack | 63629-1138 | ORAL | 400 [iU] in 1 1 | 12/30/2021 |
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 |
---|---|---|---|---|---|
BLACKMORES BIO MAGNESIUM ADVANCE + D3 | 380713 | Medicine | A | 12/13/2021 | |
Vitamin D3 Drops | 340258 | Medicine | A | 7/27/2020 | |
Nature’s Way Adult Vita Gummies Vitamin D3 1000IU | 338334 | Pharmacare Laboratories Pty Ltd | Medicine | A | 6/24/2020 |
Daily Multi Multivitamin | 337216 | Medicine | A | 5/29/2020 | |
Nature's Own Mega Magnesium with Vitamin D3 | 366379 | Medicine | A | 5/18/2021 | |
Premium Shark Cartilage plus joint support | 444127 | Medicine | A | 3/21/2024 | |
Bioglan Therapeutic Gummies Vitamin D3 1000IU | 427777 | Medicine | A | 11/13/2023 | |
My Vit Women’s Breastfeeding and Pregnancy | 349252 | Medicine | A | 11/23/2020 | |
Immune Support | 447698 | Medicine | A | 5/2/2024 | |
US Biostime MamaBiotic Plus Pre-Pregnancy Fertility Support | 408534 | Medicine | A | 5/5/2023 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
SWISS TOTAL ONE | swiss herbal remedies ltd. | 02248627 | Tablet - Oral | 200.0 UNIT | 1/5/2004 |
PRENAVITE FORTE TABLETS | roberts pharmaceutical canada inc. | 02063182 | Tablet - Oral | 400 UNIT / TAB | 12/31/1995 |
ULTRAVITE FORTE WITH MINERALS 29 | stanley pharmaceuticals, a division of vita health products inc. | 01994379 | Tablet - Oral | 400 UNIT | 12/31/1992 |
WOMAN'S DAILY SPECTRUM TABLETS | pharmetics (2011) inc | 02240019 | Tablet - Oral | 200 UNIT / TAB | 8/18/1999 |
SOLOTRON - TAB ORL | general nutrition canada inc. | 02228734 | Tablet - Oral | 400 UNIT | 8/1/2000 |
OSTEO-PLUS | rolmex international inc. | 02242649 | Tablet - Oral | 65 UNIT | 9/15/2000 |
SPECTRUM FORTE 29 TAB | ksl pharmaceuticals | 01924877 | Tablet - Oral | 400 UNIT / TAB | 12/31/1991 |
ONE TABLET DAILY MENS FORMULA | vita health products inc | 02247241 | Tablet - Oral | 400 UNIT | 5/16/2003 |
SUPER DAILY NO 2 | w.r. enterprises inc. | 00839043 | Tablet - Oral | 400 UNIT | 12/31/1990 |
PARAMETTES CHEWABLE MULTIVITAMINS PLUS IRON | wyeth-ayerst canada inc. | 02043114 | Tablet - Oral | 400 UNIT / TAB | 12/31/1994 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
MASTICAL D 500 mg/ 400 UI COMPRIMIDOS MASTICABLES SABOR NARANJA | 65097 | COMPRIMIDO MASTICABLE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
CADELIUS D 600 MG/2000 UI COMPRIMIDOS BUCODISPERSABLES | 85269 | COMPRIMIDO BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Commercialized | |
ACIDO ALENDRONICO/COLECALCIFEROL SEMANAL TECNIGEN 70 MG/5600 UI COMPRIMIDOS EFG | Tecnimede España Industria Farmaceutica S.A. | 82759 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
COLECALCIFEROL NORMON 10.000 UI/ML GOTAS ORALES EN SOLUCIÓN | Laboratorios Normon S.A. | 89368 | GOTAS ORALES EN SOLUCIÓN | Medicamento Sujeto A Prescripción Médica | Commercialized |
COLECALCIFEROL NORMON 25.000 UI/2,5 ML SOLUCIÓN ORAL | Laboratorios Normon S.A. | 90024 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
CARBOCAL D 600 MG/400 UI COMPRIMIDOS MASTICABLES | Farmasierra Laboratorios S.L. | 65582 | COMPRIMIDO MASTICABLE | Medicamento Sujeto A Prescripción Médica | Commercialized |
DITRALIA 25.000 UI PELICULAS BUCODISPERSABLES | Ibsa Farmaceutici Italia S.R.L. | 89921 | PELICULA BUCODISPERSABLE | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
COLECALCIFEROL GEBRO 50.000 UI SOLUCION ORAL | Laboratorios Gebro Pharma S.A. | 88676 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
FOSAVANCE 70 MG/5.600 UI COMPRIMIDOS | Organon N.V. | 05310007IP3 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Commercialized |
ACIDO ALENDRONICO/COLECALCIFEROL SEMANAL STADA 70 MG/2.800 UI COMPRIMIDOS EFG | Laboratorio Stada S.L. | 83548 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
Philippines FDA Drug Approvals
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