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

NCT ID: NCT03233295

Last Updated: 2017-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-23

Study Completion Date

2016-08-27

Brief Summary

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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

Detailed Description

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Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vitamin D deficiency

Group Type EXPERIMENTAL

Vitamin D3 B.O.N. Injection

Intervention Type DRUG

cholecalciferol 200,000IU

Interventions

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Vitamin D3 B.O.N. Injection

cholecalciferol 200,000IU

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kwang Dong Pharmaceutical co., ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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KDBON-CPI-01

Identifier Type: -

Identifier Source: org_study_id

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