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NCT03233295 Clinical Trial

A Prospective, Single-centre, Open-label Study to Confirm 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, Single-centre, Open-label Study to Confirm 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 NCT03233295
Other study ID # KDBON-CPI-01
Secondary ID
Status Completed
Phase Phase 4
First received July 26, 2017
Last updated July 26, 2017
Start date October 23, 2014
Est. completion date August 27, 2016

Study information
Verified date July 2017
Source Kwang Dong Pharmaceutical co., ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Prospective, Single-centre, Open-label Study to Confirm the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in adults with Vitamin D Deficiency

Recruitment information / eligibility
Status Completed
Enrollment 108
Est. completion date August 27, 2016
Est. primary completion date August 27, 2016
Accepts healthy volunteers No
Gender All
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 Hypercalcemia

- Subjects with Hypercalciuria

- Subjects with renal impairment

- Subjects with calcium stone

- Subjects diagnosed with sarcoidosis or pseudo-hypoparathyroidism

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

Study Design

Related Conditions & MeSH terms

Intervention

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

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 serum 25(OH)D concentration 12 months
Secondary serum 1,25(OH)2D concentration 12 months
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