Burn SurgeryNCT03884036
Effect of Vitamin D in Burn Patients
A study testing Vitamin D in people with Burn Surgery, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burn Surgery
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jul 2019to Oct 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- vitamin D <30 ng/ml
- patients undergoing burn surgery
Who cannot join
- age < 18 years old
- hypercalcemia
- renal disease
- cardiac disease ( EF<40%, MI, angina)
- respiratory disease (ARDS, pneumonia)
- intubated patients
- electrical burn
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hangang Sacred Heart Hospital
Seoul, 07247
Hee Yeong Kim, MD
About this study
Official title: Effect of Vitamin D in Burn Patients: A Randomized Clinical Trial
The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization.
Read the detailed description
Vitamin D deficiency often occurs in burn patients, which may include longer hospitalization and respiratory and cardiac complications.
The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization.
- Conditions
- Burn Surgery
- Being tested
- Vitamin D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DBiological
Vitamine D
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D group | Active comparator | Vitamin D 200,000 IU (1 cc) IM Receives: Biological: Vitamin D |
| Control group | Placebo comparator | Normal saline 1 cc IM Receives: Biological: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative complications
Infection, cardiovascular complication, gastrointestinal complication, respiratory complication, renal complication, and death
Measured: Within postoperative 1 month
Secondary outcomes (1)
Vitamin D level
Serum 25-hydroxy vitamin D level
Measured: Within postoperative 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start18 Jul 2019
- Primary completionAug 2019 (estimated)
- Study completionOct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn SurgeryStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 264 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangang Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center
- Responsible party
- Principal investigator, Hee Yeong Kim, Hangang Sacred Heart Hospital
- Investigators
- Young-Kug Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884036
- Sponsor's protocol ID
- 2019-003
- Status last verified
- Aug 2019
- First submitted
- 13 Mar 2019
- Last updated
- 9 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D in Burn Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03884036
- Acronym / sponsor ID
- 2019-003
- Conditions
- Burn Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 264 participants (estimated)
- Lead sponsor
- Hangang Sacred Heart HospitalUniversity, hospital or other
- Collaborators
- Asan Medical Center
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Oct 2019 (estimated)
- First posted
- 21 Mar 2019 (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.
The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization.
Detailed description
Vitamin D deficiency often occurs in burn patients, which may include longer hospitalization and respiratory and cardiac complications.
The purpose of this study is to evaluate pre-operative vitamin D levels in patients with burn injuries and evaluate the effect of vitamin D on postoperative complications and duration of hospitalization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D group | Active comparator | Biological: Vitamin DVitamin D 200,000 IU (1 cc) IM |
| Control group | Placebo comparator | Biological: Vitamin DNormal saline 1 cc IM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- vitamin D <30 ng/ml
- patients undergoing burn surgery
Key exclusion criteria (7 listed)
- age < 18 years old
- hypercalcemia
- renal disease
- cardiac disease ( EF<40%, MI, angina)
- respiratory disease (ARDS, pneumonia)
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 DVitamine D | Biological | Control group, Vitamin D group |
Primary outcome
Incidence of postoperative complications
Time frame: Within postoperative 1 month
Infection, cardiovascular complication, gastrointestinal complication, respiratory complication, renal complication, and death
1 secondary outcome
Vitamin D level
Time frame: Within postoperative 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2019.
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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.
Young-Kug Kim, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Burn Surgery, run by Hangang Sacred Heart Hospital at 1 site in South Korea.
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 2 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: status not confirmed, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hee Yeong Kim, MD (82-2-2639-5650, kimhy@hallym.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative complications (time frame: Within postoperative 1 month). 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 9 Aug 2019.