Evaluation of Vitamin D Status in Children With Acute Burns
VitaminD
Vitamin D Deficiency in Acutely Injured Pediatric Burn Patients: Incidence, Etiology, Metabolic Sequelae and Prevention
1 other identifier
interventional
50
1 country
1
Brief Summary
To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2003
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 25, 2007
CompletedFirst Posted
Study publicly available on registry
September 27, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMay 9, 2012
May 1, 2012
6.8 years
September 25, 2007
May 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels
During acute phase postburn
Secondary Outcomes (1)
Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers
During acute phase postburn
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shriners Hospital for Children
Cincinnati, Ohio, 45229, United States
Related Publications (2)
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.
PMID: 15175591RESULTHuey 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.
PMID: 33305842DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michele M Gottschlich, PhD, RD, CNSD
Shriners Hospital for Children
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Nutrition Services
Study Record Dates
First Submitted
September 25, 2007
First Posted
September 27, 2007
Study Start
March 1, 2003
Primary Completion
December 1, 2009
Study Completion
April 1, 2011
Last Updated
May 9, 2012
Record last verified: 2012-05