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

A Prospective, Multi-centre, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02443246

Enrollment

Registered

2015-05-13

Start date

2014-11-30

Completion date

2015-12-31

Last updated

2016-07-27

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

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.

Interventions

DRUGVitamin D3 B.O.N. Injection (cholecalciferol 200,000IU)

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Primary Efficacy Endpoints (serum 25(OH)D concentration)	12 weeks	serum 25(OH)D concentration

Secondary

Measure	Time frame	Description
Secondary Efficacy Endpoints (serum 25(OH)D concentration)	24 weeks	serum 25(OH)D concentration

Outcome results

None listed

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