NCT02443246

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

July 27, 2016

Status Verified

July 1, 2016

Enrollment Period

9 months

First QC Date

May 11, 2015

Last Update Submit

July 25, 2016

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • Primary Efficacy Endpoints (serum 25(OH)D concentration)

    serum 25(OH)D concentration

    12 weeks

Secondary Outcomes (1)

  • Secondary Efficacy Endpoints (serum 25(OH)D concentration)

    24 weeks

Study Arms (2)

Vitamin D deficiency

EXPERIMENTAL

Group 1

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

Vitamin D deficiency (Low)

EXPERIMENTAL

Group 2

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

Interventions

Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU)DRUG
Vitamin D deficiencyVitamin D deficiency (Low)
PlaceboDRUG
Vitamin D deficiencyVitamin D deficiency (Low)

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with vitamin D deficiency

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2015

First Posted

May 13, 2015

Study Start

November 1, 2014

Primary Completion

August 1, 2015

Study Completion

December 1, 2015

Last Updated

July 27, 2016

Record last verified: 2016-07