Effect of Vitamin D in Burn Patients | NCT03884036

Studies
Effect of Vitamin D in Burn Patients

NCT03884036

Sponsor

Hangang Sacred Heart Hospital

Status

Unknown status

Last Update Posted

Aug 9, 2019Actual

Enrollment

264Estimated

Phase

Not Applicable

Conditions

Burn Surgery

Interventions

Vitamin D

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 18, 2019Actual

Primary Completion Date

Aug 2019Estimated

Completion Date

Oct 2019Estimated

First Submitted Date

Mar 13, 2019

First Submission Date that Met QC Criteria

Mar 19, 2019

First Posted Date

Mar 21, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2019

Last Update Posted Date

Aug 9, 2019Actual

Name	Class
Asan Medical Center	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

264Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D group	Active Comparator	Vitamin D 200,000 IU (1 cc) IM	Biological: Vitamin D
Control group	Placebo Comparator	Normal saline 1 cc IM	Biological: Vitamin D

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vitamin D	Biological	Vitamine D	Control group Vitamin D group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of postoperative complications	Infection, cardiovascular complication, gastrointestinal complication, respiratory complication, renal complication, and death	Within postoperative 1 month

Secondary Outcomes

Measure	Description	Time Frame
Vitamin D level	Serum 25-hydroxy vitamin D level	Within postoperative 14 days

Other Outcomes

Measure	Description	Time Frame
Hospital stay	Length of hospital stay	Time from operation to discharge (approximately within 1 month)

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hee Yeong Kim, MD	Contact	82-2-2639-5650		kimhy@hallym.or.kr

Overall Officials

Name	Affiliation	Role
Young-Kug Kim, MD, PhD	Asan Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hangang Sacred Heart Hospital	Recruiting	Seoul		07247	South Korea

Intervention Browse Module

MeSH Terms

ID	Term
D014807	Vitamin D

Ancestor Terms

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds

Browse Leaves

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Browse Branches

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