NCT03884036

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

July 18, 2019

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
Last Updated

August 9, 2019

Status Verified

August 1, 2019

Enrollment Period

14 days

First QC Date

March 13, 2019

Last Update Submit

August 7, 2019

Conditions

Burn Surgery

Outcome Measures

Primary Outcomes (1)

  • Incidence of postoperative complications

    Infection, cardiovascular complication, gastrointestinal complication, respiratory complication, renal complication, and death

    Within postoperative 1 month

Secondary Outcomes (1)

  • Vitamin D level

    Within postoperative 14 days

Other Outcomes (1)

  • Hospital stay

    Time from operation to discharge (approximately within 1 month)

Study Arms (2)

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

Vitamin DBIOLOGICAL

Vitamine D

Control groupVitamin D group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • vitamin D \<30 ng/ml
  • patients undergoing burn surgery

You may not qualify if:

  • age \< 18 years old
  • hypercalcemia
  • renal disease
  • cardiac disease ( EF\<40%, MI, angina)
  • respiratory disease (ARDS, pneumonia)
  • intubated patients
  • electrical burn

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangang Sacred Heart Hospital

Seoul, 07247, South Korea

RECRUITING

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Young-Kug Kim, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Yeong Kim, MD

CONTACT

82-2-2639-5650kimhy@hallym.or.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 13, 2019

First Posted

March 21, 2019

Study Start

July 18, 2019

Primary Completion

August 1, 2019

Study Completion

October 1, 2019

Last Updated

August 9, 2019

Record last verified: 2019-08

Locations

KR(1)