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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/16 | Not Applicable | Completed | |||
2025/06/05 | Phase 4 | Not yet recruiting | |||
2025/05/22 | Not Applicable | Not yet recruiting | |||
2025/05/09 | Phase 3 | Not yet recruiting | |||
2025/03/06 | Not Applicable | Not yet recruiting | |||
2024/12/24 | Not Applicable | Not yet recruiting | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2024/12/16 | Not Applicable | Recruiting | |||
2024/12/04 | Phase 4 | Completed | University of Pristina | ||
2024/11/27 | Phase 3 | Not yet recruiting | Sengkang General Hospital | ||
2024/11/26 | Phase 2 | Completed | Hasanuddin University |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
AvPAK | 50268-677 | ORAL | 400 [iU] in 1 1 | 4/12/2022 | |
Organon LLC | 78206-137 | ORAL | 2800 [iU] in 1 1 | 8/31/2021 | |
CarWin Pharmaceutical Associates, LLC | 15370-105 | ORAL | 400 [iU] in 1 1 | 1/10/2024 | |
MISSION PHARMACAL COMPANY | 0178-0812 | ORAL | 400 [iU] in 1 1 | 5/3/2010 | |
Method Pharmaceuticals, LLC | 58657-164 | ORAL | 400 [iU] in 1 1 | 12/9/2023 | |
Exeltis USA, Inc. | 0642-7473 | ORAL | 25 mg in 1 1 | 2/14/2023 | |
Centurion Labs, LLC | 23359-105 | ORAL | 400 [iU] in 1 1 | 1/22/2024 | |
Method Pharmaceuticals, LLC | 58657-324 | ORAL | 400 [iU] in 1 mL | 12/12/2023 | |
PureTek Corporation | 59088-193 | ORAL | 20 ug in 1 1 | 1/11/2023 | |
BonGeo Pharmaceuticals, Inc. | 52796-174 | ORAL | 600 [iU] in 1 1 | 2/2/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 1/4/2007 | ||
Authorised | 10/16/2009 | ||
Authorised | 8/24/2005 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
Fosamax Plus™ 70mg/2800IU Tablet | SIN13152P | TABLET | 2800 iu | 10/31/2005 | |
D-CURE ORAL SOLUTION 25000IU | SIN15254P | SOLUTION | 25000IU | 6/5/2017 | |
CERNEVIT FOR INJECTION | SIN11975P | INJECTION, POWDER, FOR SOLUTION | 220 iu/vial | 6/5/2002 | |
GP CHOLECALCIFEROL SOFTGEL CAPSULE 25,000 IU | SIN17171P | CAPSULE, LIQUID FILLED | 25,000IU | 1/27/2025 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
CERNEVIT FOR INJ | N/A | N/A | N/A | 4/18/2008 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
Kids Calcium + D3 Corbiere (export) | 286468 | Medicine | A | 3/7/2017 | |
WAGNER VITAMIN D3 1000 IU | 287327 | Medicine | A | 3/31/2017 | |
BLACKMORES SUPERKIDS MULTI CHEWABLES | 289492 | Medicine | A | 5/30/2017 | |
Flechos+ | 285828 | Medicine | A | 2/17/2017 | |
MaxN-Fuze Multivitamins | 288444 | Max Health & Living Australia Pty Ltd | Medicine | A | 5/1/2017 |
S.O.H Superior Omega 3 High Potency | 280858 | Medicine | A | 9/29/2016 | |
Ostelin Vitamin D3 1000IU Liquid | 237672 | Medicine | A | 5/13/2015 | |
KiddieCal | 332941 | Pharmametics Products A Division of Max Biocare Pty Ltd | Medicine | A | 3/31/2020 |
COTTEE DAIRYCAL 600MG CHEWABLE TABLETS STRAWBERRY FLAVOUR BULK CONTAINER | 76267 | Cottee Dairy Products Pty Ltd | Medicine | A | 9/26/2000 |
D3 + K2 Spray | 227245 | Medicine | A | 8/25/2014 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
CALCIUM MAGNESIUM-PLUS | shaklee canada inc | 00547751 | Tablet - Oral | 66.7 UNIT | 12/31/1982 |
CALMA-D | wn pharmaceuticals ltd. | 02239376 | Tablet - Oral | 200 UNIT / TAB | 1/21/1999 |
BONE MEAL A+D TAB | le naturiste j.m.b. inc. | 00385166 | Tablet - Oral | 100 UNIT | 12/31/1977 |
CALCIUM, MAGNESIUM ET VITAMINE D | gamme nature | 02247523 | Tablet - Oral | 133 UNIT | 11/13/2003 |
CENTURY PLUS | vita health products inc | N/A | Tablet - Oral | 400 UNIT / TAB | 2/5/1998 |
LIQUI CAL-D | twin laboratories inc. | 01984365 | Liquid - Oral | 20 UNIT / ML | 12/31/1995 |
REAL VITAMIN SUPPLEMENT CAP | laer products inc. | 02031272 | Capsule - Oral | 100 UNIT / CAP | 12/31/1994 |
VITAMIN D 400 IU TABLETS | swiss herbal remedies ltd. | 02229879 | Tablet - Oral | 400 UNIT | 12/11/1996 |
MELA-CAL - TAB | melaleuca of canada inc. | 02119331 | Tablet - Oral | 200 UNIT | 12/31/1996 |
MULTIPLE VITAMINS PLUS IRON FOR WOMEN | pharmetics (2011) inc | 02239678 | Tablet - Oral | 400 UNIT / TAB | 8/16/1999 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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