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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
Sponsor:
Collaborator:
Asan Medical Center
Information provided by (Responsible Party):
Hee Yeong Kim, Hangang Sacred Heart Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Burn Surgery Biological: Vitamin D Not Applicable

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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Vitamin D
Drug Information available for: Vitamin D

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of postoperative complications [ Time Frame: Within postoperative 1 month ]
    Infection, cardiovascular complication, gastrointestinal complication, respiratory complication, renal complication, and death


Secondary Outcome Measures :
  1. Vitamin D level [ Time Frame: Within postoperative 14 days ]
    Serum 25-hydroxy vitamin D level


Other Outcome Measures:
  1. Hospital stay [ Time Frame: Time from operation to discharge (approximately within 1 month) ]
    Length of hospital stay


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Hee Yeong Kim, MD 82-2-2639-5650 kimhy@hallym.or.kr

Locations
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Korea, Republic of
Hangang Sacred Heart Hospital Recruiting
Seoul, Korea, Republic of, 07247
Contact: Hee Yeong Kim, MD         
Sponsors and Collaborators
Hangang Sacred Heart Hospital
Asan Medical Center
Investigators
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Principal Investigator: Young-Kug Kim, MD, PhD Asan Medical Center
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Burns
Wounds and Injuries
Vitamin D
Vitamins
Micronutrients
 Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents