NCT03233295

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2014

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 23, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

July 26, 2017

Last Update Submit

July 26, 2017

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • serum 25(OH)D concentration

    12 months

Secondary Outcomes (1)

  • serum 1,25(OH)2D concentration

    12 months

Study Arms (1)

Vitamin D deficiency

EXPERIMENTAL
Drug: Vitamin D3 B.O.N. Injection

Interventions

Vitamin D3 B.O.N. InjectionDRUG

cholecalciferol 200,000IU

Vitamin D deficiency

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2017

First Posted

July 28, 2017

Study Start

October 23, 2014

Primary Completion

August 27, 2016

Study Completion

August 27, 2016

Last Updated

July 28, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share