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CompletedNCT02443246Updated Jul 27, 2016

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 Phase 3 interventional study of Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU) and Placebo in Vitamin D Deficiency, sponsored by Kwang Dong Pharmaceutical co., ltd.. Completed. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-07-27.

Sponsored by Kwang Dong Pharmaceutical co., ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Vitamin D Deficiency

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03

In context

Vitamin D Deficiency

772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.

This study's enrollment of 84 is close to the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

Kwang Dong Pharmaceutical co., ltd. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Subjects with vitamin D deficiency

Exclusion criteria

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Vitamin D deficiency

    Group 1

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

  • Experimental
    Vitamin D deficiency (Low)

    Group 2

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

Interventions

  • DrugVitamin D3 B.O.N. Injection (cholecalciferol 200,000IU)
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Primary Efficacy Endpoints (serum 25(OH)D concentration)

    serum 25(OH)D concentration

    Time frame: 12 weeks

Secondary outcomes

  1. Secondary Efficacy Endpoints (serum 25(OH)D concentration)

    serum 25(OH)D concentration

    Time frame: 24 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02443246
Lead sponsor
Kwang Dong Pharmaceutical co., ltd.
Responsible party
Sponsor
First posted
May 13, 2015
Start date
Nov 2014
Primary completion
Aug 2015
Completion
Dec 2015
Last update
Jul 27, 2016

Study contacts

Sung-Kil Lim, Professor
principal investigator · Severance Hospital Seoul, Korea
Yun-seok Jeong, Professor
principal investigator · Ajou University Hospital, Korea
Han-seok Choi, Professor
principal investigator · Dongguk University Ilsan Hospital, Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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