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

Kwang Dong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Vitamin D Deficiency

Treatments: Drug: Placebo; Drug: Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02443246

KDBON-302

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

84 participants in 2 patient groups

Vitamin D deficiency

Experimental group

Description:

Group 1

Treatment:

Drug: Placebo

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

Vitamin D deficiency (Low)

Experimental group

Description:

Group 2

Treatment:

Drug: Placebo

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