MedPath

Vitamin D3

Generic Name
Vitamin D3
Brand Names
Adrovance, Animi-3 With Vitamin D, Citranatal B-calm Kit, Citranatal Harmony, Fosamax Plus D, Fosavance, Infuvite, Infuvite Pediatric, Mvc-fluoride, Natafort, Pregvit, Vidextra, Vantavo (previously Alendronate sodium and colecalciferol, MSD)
Drug Type
Small Molecule
Chemical Formula
C27H44O
CAS Number
67-97-0
Unique Ingredient Identifier
1C6V77QF41

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

Published: Jul 14, 2025

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.

Continue reading the full research report

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

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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