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

July 25, 2016 updated by: Kwang Dong Pharmaceutical co., ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D deficiency
Group 1
Drug: Placebo
Drug: Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU)
Experimental: Vitamin D deficiency (Low)
Group 2
Drug: Placebo
Drug: Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Efficacy Endpoints (serum 25(OH)D concentration)
Time Frame: 12 weeks
serum 25(OH)D concentration
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Efficacy Endpoints (serum 25(OH)D concentration)
Time Frame: 24 weeks
serum 25(OH)D concentration
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kwang Dong Pharmaceutical co., ltd.

Investigators

  • Principal Investigator: Sung-Kil Lim, Professor, Severance Hospital Seoul, Korea
  • Principal Investigator: Yun-seok Jeong, Professor, Ajou University Hospital, Korea
  • Principal Investigator: Han-seok Choi, Professor, Dongguk University Ilsan Hospital, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

May 11, 2015

First Submitted That Met QC Criteria

May 12, 2015

First Posted (Estimate)

May 13, 2015

Study Record Updates

Last Update Posted (Estimate)

July 27, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KDBON-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vitamin D Deficiency

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe