Vitamin D DeficiencyPhase 4NCT03233295
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 Phase 4 study testing Vitamin D3 B.O.N. Injection in people with Vitamin D Deficiency, run by Kwang Dong Pharmaceutical co., ltd..
Trial 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 Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D3 B.O.N. Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2014to 27 Aug 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with vitamin D deficiency
Who cannot join
- 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
About this study
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
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D3 B.O.N. Injection
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3 B.O.N. InjectionDrug
cholecalciferol 200,000IU
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D deficiency | Experimental | Not described Receives: Drug: Vitamin D3 B.O.N. Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25(OH)D concentration
Measured: 12 months
Secondary outcomes (1)
serum 1,25(OH)2D concentration
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start23 Oct 2014
- Primary completion27 Aug 2016
- Study completion27 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwang Dong Pharmaceutical co., ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233295
- Sponsor's protocol ID
- KDBON-CPI-01
- Status last verified
- Jul 2017
- First submitted
- 26 Jul 2017
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03233295
- Acronym / sponsor ID
- KDBON-CPI-01
- Conditions
- Vitamin D Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Kwang Dong Pharmaceutical co., ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Oct 2014 (actual)
- Primary completion
- 27 Aug 2016 (actual)
- Study completion
- 27 Aug 2016 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin D deficiency | Experimental | Drug: Vitamin D3 B.O.N. Injection |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with vitamin D deficiency
Key exclusion criteria (7 listed)
- Subjects who experienced a hypersensitivity to the cholecalciferol
- Subjects with Hypercalcemia
- Subjects with Hypercalciuria
- Subjects with renal impairment
- Subjects with calcium stone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D3 B.O.N. Injectioncholecalciferol 200,000IU | Drug | Vitamin D deficiency |
Primary outcome
serum 25(OH)D concentration
Time frame: 12 months
1 secondary outcome
serum 1,25(OH)2D concentration
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D3 B.O.N. Injection in people with Vitamin D Deficiency, run by Kwang Dong Pharmaceutical co., ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum 25(OH)D concentration (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.