Ergocalciferol

Overview

Ergocalciferol is an inactivated vitamin D analog. It is synthesized by some plants in the presence of UVB light. The production of ergocalciferol was prompted by the identification of dietary deficiency, more specifically vitamin D, as the main causative factor for the development of rickets. Ergocalciferol was isolated for the first time from yeast in 1931 and its structure was elucidated in 1932. Ergocalciferol is considered the first vitamin D analog and is differentiated from cholecalciferol by the presence of a double bond between C22 and C23 and the presence of a methyl group at C24. These modifications reduce the affinity of ergocalciferol for the vitamin D binding protein resulting in faster clearance, limits its activation, and alters its catabolism. The first approved product containing ergocalciferol under the FDA records was developed by US Pharm Holdings and was FDA approved in 1941.

Indication

Ergocalciferol is indicated for the treatment of hypoparathyroidism, refractory rickets, and familial hypophosphatemia. Hypoparathyroidism is the result of inadequate parathyroid hormone production that occurs due to the presence of damage or removal of the parathyroid glands. This condition produces decreased calcium and increased phosphorus levels. Rickets is a condition produced due to a deficiency in vitamin D, calcium or phosphorus. However, this condition can also be related to renal diseases. It is characterized to present weak or soft bones. Familial hypophosphatemia is characterized by the impaired transport of phosphate and an altered vitamin D metabolism in the kidneys. The presence of this condition can derive in the presence of osteomalacia, bone softening and rickets.

Associated Conditions

Deficiency, Vitamin A
Deficiency, Vitamin D
Hypoparathyroidism
Hypophosphatemia, Familial
Vitamin D Resistant Rickets

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Oral Vitamin D2 for Prevention of COVID-19	2023/01/06	NCT05673980	Not Applicable	Recruiting	Peking University Third Hospital
Immune Mechanisms of Vitamin D to Reduce Chronic Pain After Burn	2022/11/16	NCT05619289	Phase 2	Recruiting	University of North Carolina, Chapel Hill
Vitamin D to ENhance TraUma REcovery	2022/07/14	NCT05458024	Phase 2	Completed	University of North Carolina, Chapel Hill
The Effects of Vitamin D and Calcium Supplementation to Parathyroid Hormone in CHB Patients Treated With TDF	2022/04/06	NCT05313477	Phase 4	Completed	Mahidol University
Vitamin D Supplementation on Reported Rates of Taxane-Induced Neuropathy	2022/02/28	NCT05259527	Phase 2	Recruiting	Virginia Commonwealth University
Vitamin D Deficiency in Adults Following a Major Burn Injury	2021/10/19	NCT05084248	Phase 4	Recruiting	University of Texas Southwestern Medical Center
Vitamin D Supplementation on Outcome and Disease Activity.	2021/06/02	NCT04909931	Not Applicable	Completed	Rajavithi Hospital
The Role of Vitamin D Supplementation on Pain in Women With Primary Dysmenorrhea and Hypovitaminosis D	2021/04/02	NCT04829487	Not Applicable	UNKNOWN	Mahidol University
Pregnancy Outcome and Vitamin D Level Among Vitamin D Supplementation During Pregnancy	2020/10/19	NCT04591847	Phase 3	Completed	Rajavithi Hospital
Vitamin D Effect in Rheumatoid Arthritis.	2020/07/15	NCT04472481	Phase 4	Completed	Tanta University

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Ergocalciferol Capsules,	Proficient Rx LP	71205-676	ORAL	1.25 mg in 1 1	7/1/2022
VITAMIN D	Aphena Pharma Solutions - Tennessee, LLC	71610-552	ORAL	1.25 mg in 1 1	8/28/2023
Ergocalciferol	Aphena Pharma Solutions - Tennessee, LLC	71610-712	ORAL	1.25 mg in 1 1	8/18/2023
Ergocalciferol	Bionpharma Inc.	69452-151	ORAL	1.25 mg in 1 1	12/27/2023
Ergocalciferol	Dispensing Solutions, Inc.	66336-907	ORAL	1.25 mg in 1 1	2/6/2012
Ergocalciferol	Aphena Pharma Solutions - Tennessee, LLC	43353-219	ORAL	1.25 mg in 1 1	5/26/2017
Vitamin D	NuCare Pharmaceuticals,Inc.	68071-2352	ORAL	1.25 mg in 1 1	12/22/2022
DRISDOL	Validus Pharmaceuticals LLC	30698-493	ORAL	1.25 mg in 1 1	5/8/2023
Ergocalciferol	SigmaPharm Laboratories, LLC	42794-006	ORAL	1.25 mg in 1 1	1/25/2012
Ergocalciferol Capsules,	Epic Pharma LLC	42806-547	ORAL	1.25 mg in 1 1	10/31/2019

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
VITALIPID N INFANT INJECTION	FRESENIUS KABI AB	SIN05207P	INJECTION	40 iu/ml	11/14/1990
VITALIPID N ADULT INJECTION	FRESENIUS KABI AB	SIN05208P	INJECTION	20 iu/ml	11/14/1990
TAMIPOOL FOR INJECTION	CELLTRION PHARM, INC.	SIN11849P	INJECTION, POWDER, FOR SOLUTION	200 iu/vial	3/15/2002

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
FOREST PHARMA WITH AMINO ACIDS capsule carton	51067	Forest Pharmatech Pty Limited	Medicine	A	12/7/1994
Vital Kids	206084	Martin & Pleasance Pty Ltd	Medicine	A	2/13/2013
Bio-Enhanced Liquid Calcium plus Vitamin D	91955	Nature's Care Manufacture Pty Limited	Medicine	A	11/20/2002
Fitline Heart Duo Microsolve+	496608	PM International Australia Pty Ltd	Medicine	A	7/3/2025
VITALIPID N INFANT 10mL injection emulsion ampoule	40253	Fresenius Kabi Australia Pty Ltd	Medicine	A	8/21/1992
HYDRODOL Before	320523	Substance Pty Ltd	Medicine	A	7/22/2019
Hydrodol Before Powder	345274	Substance Pty Ltd	Medicine	A	9/30/2020
Skin Vitality	395171	Healthcare Product Agency Australia Pty Ltd	Medicine	A	8/31/2022
VITALIPID N ADULT 10mL injection ampoule	40252	Fresenius Kabi Australia Pty Ltd	Medicine	A	8/21/1992
HYDRODOL REHYDRATION + IMMUNITY POWDER HONEY LEMON FLAVOUR	427925	Substance Pty Ltd	Medicine	A	11/15/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
CAL/MAG 2:1 WITH D	wn pharmaceuticals ltd.	02231795	Tablet - Oral	100 UNIT / TAB	6/26/1998
OSTO-D2	paladin pharma inc.	02301911	Capsule - Oral	50000 UNIT	2/8/2008
CHILDREN PEDIATRIC VITAMINS DROPS	stanley pharmaceuticals, a division of vita health products inc.	00732915	Drops - Oral	400 UNIT / .6 ML	12/31/1990
NOVIM 60 JR CHEWABLE FOR CHILDREN	laboratoire lalco inc.	00718084	Tablet - Oral	400 UNIT / TAB	12/31/1987
RADIOSTOL CAP 50000IU	allen & hanburys a glaxo canada ltd. co.	00002690	Capsule - Oral	50000 UNIT / CAP	12/15/1989
INFANT'S MULTIPLE VITAMIN DROPS	stanley pharmaceuticals, a division of vita health products inc.	01939165	Liquid - Oral	400 UNIT / .6 ML	12/31/1991
MYCELIZED CHILDRENS MULTI-VITAMIN LIQ	METAGENICS, INC.	00653829	Drops - Oral	200 UNIT / 1 ML	12/31/1985
FOR MEN TAB	jamieson laboratories ltd	02025167	Tablet - Oral	200 UNIT / TAB	12/31/1993
CALCIUM MAGNESIUM PLUS VITAMIN D LIQUID	Jamp Pharma Corporation	02198711	Liquid - Oral	2 UNIT / ML	4/22/2002
DINOMALS	awareness corporation	02237540	Liquid - Oral	400 UNIT / 10 ML	2/10/2001

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
VITALIPID INFANTIL	Fresenius Kabi España, S.A.U.	61021	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized
VITALIPID ADULTOS	Fresenius Kabi España, S.A.U.	61020	CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN	Uso Hospitalario	Commercialized

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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