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

Kwang Dong Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Vitamin D Deficiency

Treatments: Drug: Vitamin D3 B.O.N. Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT03233295

KDBON-CPI-01

Details and patient eligibility

About

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

Enrollment: 108 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 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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108 participants in 1 patient group

Vitamin D deficiency

Experimental group

Treatment:

Drug: Vitamin D3 B.O.N. Injection