Back to resultsA 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
Primary Purpose
Vitamin D Deficiency
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Vitamin D3 B.O.N. Injection
Sponsored by
About this trial
This is an interventional treatment trial for Vitamin D Deficiency
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vitamin D deficiency
Arm Description
Outcomes
Primary Outcome Measures
serum 25(OH)D concentration
Secondary Outcome Measures
serum 1,25(OH)2D concentration
Full Information
NCT ID
NCT03233295
First Posted
July 26, 2017
Last Updated
July 26, 2017
Sponsor
Kwang Dong Pharmaceutical co., ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03233295
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 23, 2014 (Actual)
Primary Completion Date
August 27, 2016 (Actual)
Study Completion Date
August 27, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kwang Dong Pharmaceutical co., ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
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 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitamin D deficiency
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Vitamin D3 B.O.N. Injection
Intervention Description
cholecalciferol 200,000IU
Primary Outcome Measure Information:
Title
serum 25(OH)D concentration
Time Frame
12 months
Secondary Outcome Measure Information:
Title
serum 1,25(OH)2D concentration
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this 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
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