A Prospective, Multi-center Study to Evaluate the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency

Vitamin D Deficiency Clinical Trial

Official title:

A Prospective, Multi-centre, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443246
• Other study ID #: KDBON-302
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2015
• Last updated: July 25, 2016
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: July 2016
• Source: Kwang Dong Pharmaceutical co., ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

To compare the efficacy of Vitamin D3 B.O.N. Intramuscular Injection within 12 weeks with that of placebo in adults with Vitamin D Deficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 65 Years

Eligibility

Inclusion Criteria:

• Subjects with vitamin D deficiency

Exclusion Criteria:

• Subjects who experienced a hypersensitivity to the cholecalciferol

• Subjects with renal impairment

• Subjects with Hypercalcemia

• Subjects with Hypercalciuria

• Subjects with clinically doubted calcium stone

• Subjects diagnosed with sarcoidosis

• Subjected diagnosed with pseudo-hypoparathyroidism

• Subjected with malignancy

• Subjects with clinically significant cardiovascular or lung impairment Judged by the investigator

• Subjects with the below laboratory abnormality (Platelet, WBC, Absolute neutrophil count, Albumin, AST or ALT)

• Subjects who are to take vitamin D supplements during the study period

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Drug:
• Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU)

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kwang Dong Pharmaceutical co., ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoints (serum 25(OH)D concentration)	serum 25(OH)D concentration	12 weeks	No
Secondary	Secondary Efficacy Endpoints (serum 25(OH)D concentration)	serum 25(OH)D concentration	24 weeks	No