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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Vitamin D deficiency

Group 1

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Vitamin D deficiency (Low)

Group 2

Group Type EXPERIMENTAL

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No