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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

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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

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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

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PPB Drug Approvals

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TGA Drug Approvals

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Health Canada Drug Approvals

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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

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Company
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Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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Saudi SFDA Drug Approvals

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