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Evaluation of Vitamin D Status in Children With Acute Burns (VitaminD)

Primary Purpose

Burns, Bone Demineralization

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vitamin D2
Vitamin D3
Sponsored by
Shriners Hospitals for Children
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring vitamin D

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Child is > 6 months of age but < 19 years old
  • Burn injury > 30% total body surface area
  • Admitted to SHC within 4 days of injury
  • Attending physician decision that patient is likely to survive
  • Parents or legal guardian give informed consent along with assent of the child as applicable

Exclusion Criteria:

  • Attending physician decision that patient is not likely to survive
  • Prior history of anticonvulsant or glucocorticoid use, gastric/bowel resection, parathyroid disease, liver disease, chronic renal failure or prior pharmacologic vitamin D use (>1000 IU/D)

Sites / Locations

  • Shriners Hospital for Children

Outcomes

Primary Outcome Measures

Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels

Secondary Outcome Measures

Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers

Full Information

First Posted
September 25, 2007
Last Updated
May 8, 2012
Sponsor
Shriners Hospitals for Children
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1. Study Identification

Unique Protocol Identification Number
NCT00536276
Brief Title
Evaluation of Vitamin D Status in Children With Acute Burns
Acronym
VitaminD
Official Title
Vitamin D Deficiency in Acutely Injured Pediatric Burn Patients: Incidence, Etiology, Metabolic Sequelae and Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shriners Hospitals for Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.
Detailed Description
The purpose of this study is to follow up our descriptive observations with a prospective randomized double blinded study to verify our clinical perception that hypovitaminosis D is prevalent postburn and to evaluate whether therapeutic supplementation will enhance specific primary outcome measures during burn convalescence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Bone Demineralization
Keywords
vitamin D

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D2
Other Intervention Name(s)
ergocalciferol
Intervention Description
Daily enteral dose of 100IU/kg
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
Daily enteral dose of 100IU/kg
Primary Outcome Measure Information:
Title
Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels
Time Frame
During acute phase postburn
Secondary Outcome Measure Information:
Title
Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers
Time Frame
During acute phase postburn

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child is > 6 months of age but < 19 years old Burn injury > 30% total body surface area Admitted to SHC within 4 days of injury Attending physician decision that patient is likely to survive Parents or legal guardian give informed consent along with assent of the child as applicable Exclusion Criteria: Attending physician decision that patient is not likely to survive Prior history of anticonvulsant or glucocorticoid use, gastric/bowel resection, parathyroid disease, liver disease, chronic renal failure or prior pharmacologic vitamin D use (>1000 IU/D)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele M Gottschlich, PhD, RD, CNSD
Organizational Affiliation
Shriners Hospital for Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shriners Hospital for Children
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15175591
Citation
Gottschlich MM, Mayes T, Khoury J, Warden GD. Hypovitaminosis D in acutely injured pediatric burn patients. J Am Diet Assoc. 2004 Jun;104(6):931-41, quiz 1031. doi: 10.1016/j.jada.2004.03.020.
Results Reference
result
PubMed Identifier
33305842
Citation
Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
Results Reference
derived

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Evaluation of Vitamin D Status in Children With Acute Burns

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