Skip to main content
OpenTrials
Completed

NCT Number: NCT02443246

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Placebo

Drug

Primary outcomes

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

    Time frame: 12 weeks

    serum 25(OH)D concentration

Secondary outcomes

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

    Time frame: 24 weeks

    serum 25(OH)D concentration

Sponsors and collaborators

Lead sponsor

Kwang Dong Pharmaceutical co., ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 13, 2015
Registry last updated
Jul 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.