Effect of Vitamin D in Burn Patients

Effect of Vitamin D in Burn Patients: A Randomized Clinical Trial

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 Overview

• Status: Unknown
• Conditions: Burn Surgery
• Intervention / Treatment: Biological: Vitamin D

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 Type: Interventional
• Enrollment (Anticipated): 264
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hee Yeong Kim, MD; Phone Number: 82-2-2639-5650; Email: kimhy@hallym.or.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 07247
    • Recruiting
    • Hangang Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hangang Sacred Heart Hospital
• Collaborators: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2019
• Primary Completion (Anticipated): August 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 19, 2019
• First Posted (Actual): March 21, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 2019-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No