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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

Primary Purpose

Vitamin D Deficiency

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

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

Placebo

About this trial

This is an interventional treatment trial for Vitamin D Deficiency

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Vitamin D deficiency

Vitamin D deficiency (Low)

Arm Description

Group 1

Group 2

Outcomes

Primary Outcome Measures

Primary Efficacy Endpoints (serum 25(OH)D concentration)

serum 25(OH)D concentration

Secondary Outcome Measures

Secondary Efficacy Endpoints (serum 25(OH)D concentration)

serum 25(OH)D concentration

Full Information

NCT ID

NCT02443246

First Posted

May 11, 2015

Last Updated

July 25, 2016

Sponsor

Kwang Dong Pharmaceutical co., ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02443246

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kwang Dong Pharmaceutical co., ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

84 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin D deficiency

Arm Type

Experimental

Arm Description

Group 1

Arm Title

Vitamin D deficiency (Low)

Arm Type

Experimental

Arm Description

Group 2

Intervention Type

Drug

Intervention Name(s)

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Primary Efficacy Endpoints (serum 25(OH)D concentration)

Description

serum 25(OH)D concentration

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Secondary Efficacy Endpoints (serum 25(OH)D concentration)

Description

serum 25(OH)D concentration

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sung-Kil Lim, Professor

Organizational Affiliation

Severance Hospital Seoul, Korea

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yun-seok Jeong, Professor

Organizational Affiliation

Ajou University Hospital, Korea

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Han-seok Choi, Professor

Organizational Affiliation

Dongguk University Ilsan Hospital, Korea

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

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

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