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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kwang Dong Pharmaceutical co., ltd.
• Treatments: Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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