Effect of Vitamin D in Burn Patients

NCT ID: NCT03884036

Last Updated: 2019-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

264 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-18

Study Completion Date

2019-10-31

Brief Summary

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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

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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

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Burn Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vitamin D group

Vitamin D 200,000 IU (1 cc) IM

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type BIOLOGICAL

Vitamine D

Control group

Normal saline 1 cc IM

Group Type PLACEBO_COMPARATOR

Vitamin D

Intervention Type BIOLOGICAL

Vitamine D

Interventions

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Vitamin D

Vitamine D

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role collaborator

Hangang Sacred Heart Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hee Yeong Kim

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Young-Kug Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Hangang Sacred Heart Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hee Yeong Kim, MD

Role: CONTACT

82-2-2639-5650

Facility Contacts

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Hee Yeong Kim, MD

Role: primary

Other Identifiers

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2019-003

Identifier Type: -

Identifier Source: org_study_id

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