Vitamin D DeficiencyPhase 3NCT02443246
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
A Phase 3 study testing Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU) in people with Vitamin D Deficiency, run by Kwang Dong Pharmaceutical co., ltd..
Trial 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. 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 (cholecalciferol 200,000IU)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Dec 2015
- Phase
- Phase 3
- 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 renal impairment
- Subjects with Hypercalcemia
- Subjects with Hypercalciuria
- Subjects with clinically doubted calcium stone
- Subjects diagnosed with sarcoidosis
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- 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
About this study
Official title: A Prospective, Multi-centre, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency
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.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU), Placebo
- 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. Injection (cholecalciferol 200,000IU)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D deficiency | Experimental | Group 1 Receives: Drug: Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU); Drug: Placebo |
| Vitamin D deficiency (Low) | Experimental | Group 2 Receives: Drug: Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoints (serum 25(OH)D concentration)
serum 25(OH)D concentration
Measured: 12 weeks
Secondary outcomes (1)
Secondary Efficacy Endpoints (serum 25(OH)D concentration)
serum 25(OH)D concentration
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2015 (estimated)
- Study startNov 2014
- Primary completionAug 2015
- Study completionDec 2015
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kwang Dong Pharmaceutical co., ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung-Kil Lim, Professor, Principal investigator, Severance Hospital Seoul, KoreaYun-seok Jeong, Professor, Principal investigator, Ajou University Hospital, KoreaHan-seok Choi, Professor, Principal investigator, Dongguk University Ilsan Hospital, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02443246
- Sponsor's protocol ID
- KDBON-302
- Status last verified
- Jul 2016
- First submitted
- 11 May 2015
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-centre, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Vitamin D3 B.O.N. Intramuscular Injection in Adults With Vitamin D Deficiency
- ClinicalTrials.gov ID
- NCT02443246
- Acronym / sponsor ID
- KDBON-302
- Conditions
- Vitamin D Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Kwang Dong Pharmaceutical co., ltd.Industry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 13 May 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D deficiency | Experimental | Drug: Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU), Drug: PlaceboGroup 1 |
| Vitamin D deficiency (Low) | Experimental | Drug: Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU), Drug: PlaceboGroup 2 |
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 (11 listed)
- Subjects who experienced a hypersensitivity to the cholecalciferol
- Subjects with renal impairment
- Subjects with Hypercalcemia
- Subjects with Hypercalciuria
- Subjects with clinically doubted 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. Injection (cholecalciferol 200,000IU) | Drug | Vitamin D deficiency, Vitamin D deficiency (Low) |
| Placebo | Drug | Vitamin D deficiency, Vitamin D deficiency (Low) |
Primary outcome
Primary Efficacy Endpoints (serum 25(OH)D concentration)
Time frame: 12 weeks
serum 25(OH)D concentration
1 secondary outcome
Secondary Efficacy Endpoints (serum 25(OH)D concentration)
Time frame: 24 weeks
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 27 Jul 2016.
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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.
Sung-Kil Lim, Professor principal investigator
Severance Hospital Seoul, Korea
Yun-seok Jeong, Professor principal investigator
Ajou University Hospital, Korea
Han-seok Choi, Professor principal investigator
Dongguk University Ilsan Hospital, Korea
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU) 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 11 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 27 Jul 2016. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Primary Efficacy Endpoints (serum 25(OH)D concentration) (time frame: 12 weeks). 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 27 Jul 2016.