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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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03233295
Enrollment
108
Registered
2017-07-28
Start date
2014-10-23
Completion date
2016-08-27
Last updated
2017-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

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

Interventions

DRUGVitamin D3 B.O.N. Injection

cholecalciferol 200,000IU

Sponsors

Kwang Dong Pharmaceutical co., ltd.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
serum 25(OH)D concentration12 months

Secondary

MeasureTime frame
serum 1,25(OH)2D concentration12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026