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OpenTrials
Completed

NCT Number: NCT03233295

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

Completed

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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 4

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 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

Treatment and study plan

Vitamin D3 B.O.N. Injection

Drug

cholecalciferol 200,000IU

Primary outcomes

  1. serum 25(OH)D concentration

    Time frame: 12 months

Secondary outcomes

  1. serum 1,25(OH)2D concentration

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Kwang Dong Pharmaceutical co., ltd.

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 28, 2017
Registry last updated
Jul 28, 2017

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.

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