Effect of Vitamin D in Burn Patients
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ClinicalTrials.gov Identifier: NCT03884036 |
Recruitment Status :
Recruiting
First Posted : March 21, 2019
Last Update Posted : August 9, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Burn Surgery | Biological: Vitamin D | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 264 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Effect of Vitamin D in Burn Patients: A Randomized Clinical Trial |
Actual Study Start Date : | July 18, 2019 |
Estimated Primary Completion Date : | August 2019 |
Estimated Study Completion Date : | October 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Vitamin D group
Vitamin D 200,000 IU (1 cc) IM
|
Biological: Vitamin D
Vitamine D |
Placebo Comparator: Control group
Normal saline 1 cc IM
|
Biological: Vitamin D
Vitamine D |
- Incidence of postoperative complications [ Time Frame: Within postoperative 1 month ]Infection, cardiovascular complication, gastrointestinal complication, respiratory complication, renal complication, and death
- Vitamin D level [ Time Frame: Within postoperative 14 days ]Serum 25-hydroxy vitamin D level
- Hospital stay [ Time Frame: Time from operation to discharge (approximately within 1 month) ]Length of hospital stay

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- vitamin D <30 ng/ml
- patients undergoing burn surgery
Exclusion Criteria:
- age < 18 years old
- hypercalcemia
- renal disease
- cardiac disease ( EF<40%, MI, angina)
- respiratory disease (ARDS, pneumonia)
- intubated patients
- electrical burn

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884036
Contact: Hee Yeong Kim, MD | 82-2-2639-5650 | kimhy@hallym.or.kr |
Korea, Republic of | |
Hangang Sacred Heart Hospital | Recruiting |
Seoul, Korea, Republic of, 07247 | |
Contact: Hee Yeong Kim, MD |
Principal Investigator: | Young-Kug Kim, MD, PhD | Asan Medical Center |
Responsible Party: | Hee Yeong Kim, Assistant Professor, Hangang Sacred Heart Hospital |
ClinicalTrials.gov Identifier: | NCT03884036 |
Other Study ID Numbers: |
2019-003 |
First Posted: | March 21, 2019 Key Record Dates |
Last Update Posted: | August 9, 2019 |
Last Verified: | August 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Burns Wounds and Injuries Vitamin D Vitamins Micronutrients |
Nutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents |