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Effect of Vitamin D in Burn Patients

Primary Purpose

Burn Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Vitamin D
Sponsored by
Hangang Sacred Heart Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Burn Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hangang Sacred Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Vitamin D group

Control group

Arm Description

Vitamin D 200,000 IU (1 cc) IM

Normal saline 1 cc IM

Outcomes

Primary Outcome Measures

Incidence of postoperative complications
Infection, cardiovascular complication, gastrointestinal complication, respiratory complication, renal complication, and death

Secondary Outcome Measures

Vitamin D level
Serum 25-hydroxy vitamin D level

Full Information

First Posted
March 13, 2019
Last Updated
August 7, 2019
Sponsor
Hangang Sacred Heart Hospital
Collaborators
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03884036
Brief Title
Effect of Vitamin D in Burn Patients
Official Title
Effect of Vitamin D in Burn Patients: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 18, 2019 (Actual)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hangang Sacred Heart Hospital
Collaborators
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
264 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D group
Arm Type
Active Comparator
Arm Description
Vitamin D 200,000 IU (1 cc) IM
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Normal saline 1 cc IM
Intervention Type
Biological
Intervention Name(s)
Vitamin D
Intervention Description
Vitamine D
Primary Outcome Measure Information:
Title
Incidence of postoperative complications
Description
Infection, cardiovascular complication, gastrointestinal complication, respiratory complication, renal complication, and death
Time Frame
Within postoperative 1 month
Secondary Outcome Measure Information:
Title
Vitamin D level
Description
Serum 25-hydroxy vitamin D level
Time Frame
Within postoperative 14 days
Other Pre-specified Outcome Measures:
Title
Hospital stay
Description
Length of hospital stay
Time Frame
Time from operation to discharge (approximately within 1 month)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hee Yeong Kim, MD
Phone
82-2-2639-5650
Email
kimhy@hallym.or.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Kug Kim, MD, PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hangang Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
07247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hee Yeong Kim, MD

12. IPD Sharing Statement

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Effect of Vitamin D in Burn Patients

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