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
Phase 3
Completed
- Conditions
- Vitamin D Deficiency
- Interventions
- Drug: Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU)Drug: Placebo
- Registration Number
- NCT02443246
- Lead Sponsor
- Kwang Dong Pharmaceutical co., ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin D deficiency Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU) Group 1 Vitamin D deficiency (Low) Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU) Group 2 Vitamin D deficiency Placebo Group 1 Vitamin D deficiency (Low) Placebo Group 2
- Primary Outcome Measures
Name Time Method Primary Efficacy Endpoints (serum 25(OH)D concentration) 12 weeks serum 25(OH)D concentration
- Secondary Outcome Measures
Name Time Method Secondary Efficacy Endpoints (serum 25(OH)D concentration) 24 weeks serum 25(OH)D concentration