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
View More Clinical Trials
Sign in to access the complete clinical trial database with detailed study information.
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2021/10/15 | Not Applicable | UNKNOWN | Baqai Institute of Diabetology and Endocrinology | ||
2021/09/08 | Phase 4 | Completed | Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health | ||
2021/09/05 | Not Applicable | Recruiting | |||
2021/08/17 | Phase 2 | Completed | |||
2021/08/05 | Phase 3 | Completed | University Hospital, Basel, Switzerland | ||
2021/07/07 | Phase 4 | Completed | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2021/06/25 | Early Phase 1 | Completed | Louisiana State University Health Sciences Center Shreveport | ||
2021/06/08 | Phase 2 | UNKNOWN | |||
2021/06/08 | Phase 1 | UNKNOWN | rana alaaeldin aly ibrahim nasr | ||
2021/04/19 | Phase 3 | Completed |
FDA Drug Approvals
View More FDA Approvals
Sign in to access additional FDA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Pharmics, Inc. | 0813-0202 | ORAL | 400 [iU] in 1 1 | 9/6/2012 | |
JayMac Pharmaceuticals LLC | 64661-811 | ORAL | 400 [iU] in 1 1 | 5/3/2012 | |
PureTek Corporation | 59088-168 | ORAL | 20 ug in 1 1 | 1/11/2023 | |
Bryant Ranch Prepack | 63629-3545 | ORAL | 400 [iU] in 1 1 | 7/17/2014 | |
CarWin Pharmaceutical Associates, LLC | 15370-100 | ORAL | 400 [iU] in 1 mL | 8/3/2017 | |
PureTek Corporation | 59088-186 | ORAL | 20 ug in 1 1 | 1/11/2023 | |
MISSION PHARMACAL COMPANY | 0178-0798 | ORAL | 400 [iU] in 1 1 | 1/18/2012 | |
CarWin Pharmaceutical Associates, LLC | 15370-250 | ORAL | 1000 [iU] in 1 1 | 12/23/2019 | |
Everett Laboratories, Inc. | 0642-0120 | ORAL | 400 [iU] in 1 1 | 7/21/2014 | |
Mission Pharmacal Company | 0178-0796 | ORAL | 400 [iU] in 1 1 | 1/8/2024 |
EMA Drug Approvals
View More EMA Approvals
Sign in to access additional EMA-approved drug information with detailed regulatory data.
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
View More HSA Approvals
Sign in to access additional HSA-approved drug information with detailed regulatory data.
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No HSA approvals found for this drug. |
NMPA Drug Approvals
View More NMPA Approvals
Sign in to access additional NMPA-approved drug information with detailed regulatory data.
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
View More PPB Approvals
Sign in to access additional PPB-approved drug information with detailed regulatory data.
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
View More TGA Approvals
Sign in to access additional TGA-approved drug information with detailed regulatory data.
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
BLACKMORES EXECUTIVE DUAL PERFORMANCE | 387420 | Medicine | A | 4/22/2022 | |
Living Healthy Calcium 600mg Plus Vitamin D 500IU | 223356 | Medicine | A | 5/12/2014 | |
Anxiety Relief (Louie Vitamins) | 462399 | Medicine | A | 9/19/2024 | |
Calcivita forte Capsules | 461727 | Medicine | A | 9/2/2024 | |
Adult Vita Gummies Women's Multivitamin | 461189 | Pharmacare Laboratories Pty Ltd | Medicine | A | 8/29/2024 |
Eye Pro+ | 462806 | Medicine | A | 9/25/2024 | |
Acaci Labs Plant Calcium Bio-advance | 462679 | Medicine | A | 9/24/2024 | |
Viteze - Vitamin D 1000 IU | 454427 | Medicine | A | 7/4/2024 | |
Priceline Women's Multi | 453994 | Medicine | A | 7/1/2024 | |
WAGNER WOMEN'S MULTIVITE | 444376 | Medicine | A | 3/25/2024 |
Health Canada Drug Approvals
View More Health Canada Approvals
Sign in to access additional Health Canada approved drug information with detailed regulatory data.
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
SUPPLEMENT DE VITAMINES ET MINERAUX | land art inc. | 02236717 | Liquid - Oral | 7 UNIT / ML | 1/20/1998 |
SPARK CAP | enrich international | 02009528 | Capsule - Oral | 100 UNIT / CAP | 12/31/1994 |
OPTIMA FORTE TAB | stanley pharmaceuticals, a division of vita health products inc. | 01924885 | Tablet - Oral | 400 UNIT | 12/31/1991 |
NUTRILITE DOUBLE X | nutrilite, a division of access business group, llc | 02246512 | Tablet - Oral | 200 UNIT | 12/15/2002 |
SPECTRUM 18 TAB | ksl pharmaceuticals | 01910434 | Tablet - Oral | 400 UNIT / TAB | 12/31/1991 |
ONE A DAY ADVANCE ADULTS - TABS | bayer inc consumer care | 02153068 | Tablet - Oral | 400 UNIT | 5/2/1996 |
VITOGEN SPECTRUM FORTE TAB | shoppers drug mart inc. | 00611735 | Tablet - Oral | 400 UNIT / TAB | 12/31/1986 |
ONE A DAY ADVANCE - ADULTS 50 + - TABS | bayer inc consumer care | 02155206 | Tablet - Oral | 400 UNIT | 12/31/1996 |
MULTIVITAMINES | rolmex international inc. | 02237421 | Tablet - Oral | 400 UNIT / TAB | 5/11/1998 |
MULTI VITAMINES JUNIOR AVEC FER | distributions multi-pro inc. | 00630454 | Tablet - Oral | 400 UNIT | 12/31/1985 |
CIMA AEMPS Drug Approvals
View More CIMA AEMPS Approvals
Sign in to access additional CIMA AEMPS approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
View More Philippines FDA Approvals
Sign in to access additional Philippines FDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
View More Saudi SFDA Approvals
Sign in to access additional Saudi SFDA approved drug information with detailed regulatory data.
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
View More Malaysia NPRA Approvals
Sign in to access additional Malaysia NPRA approved drug information with detailed regulatory data.
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
View More UK EMC Drug Information
Sign in to access additional UK EMC drug information with detailed pharmaceutical data.
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
Help Us Improve
Your feedback helps us provide better drug information and insights.