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

Phase 4

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Drug: Vitamin D3 B.O.N. Injection

• Registration Number: NCT03233295
• Lead Sponsor: Kwang Dong Pharmaceutical co., ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-23
• Primary Completion: 2016-08-27
• Study Completion: 2016-08-27
• Status Verified: 2017-07
• Study First Submitted: 2017-07-26
• Study First Submitted QC: 2017-07-26
• Last Update Submitted: 2017-07-26
• Study First Posted: 2017-07-28
• Last Update Posted: 2017-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D deficiency	Vitamin D3 B.O.N. Injection	-

Primary Outcome Measures

Name	Time	Method
serum 25(OH)D concentration	12 months

Secondary Outcome Measures

Name	Time	Method
serum 1,25(OH)2D concentration	12 months