Back to resultsEffects of Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period
Primary Purpose
Vitamin D, Burn Injury
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Cholecalciferol
Sponsored by
About this trial
This is an interventional supportive care trial for Vitamin D
Eligibility Criteria
Inclusion Criteria:
- occurrence of injury between 2005 and 2011
- burn surface area (BSA) greater than 10%
Exclusion Criteria:
- Pregnancy, renal or liver failure, hypo or hyperparathyroidism, prior vitamin D substitution, treatment using systemic corticosteroids or antiepileptic drugs, regular exposure to ultraviolet B radiation (solarium), unstable cardiovascular disease or acute muscle or skeletal injury prohibiting physical exercise
Sites / Locations
- Burn Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cholecalciferol
Arm Description
Outcomes
Primary Outcome Measures
calcidiol blood concentration
Secondary Outcome Measures
bone health
bone formation and resorption markers (blood concentrations) bone mineral density measurement using dual energy X-ray absorptiometry
muscle strength
Measurements of knee muscles strength on an isokinetic dynamometer
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02092701
Brief Title
Effects of Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period
Official Title
Effects of a One Year Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Liege
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Vitamin D has pleiotropic effects. Burn patients are at risk of hypovitaminosis D and may experience post-injury osteopenia and sarcopenia. Investigators hypothesized that vitamin D supplementation during one year can improve bone and muscle health in post-burn period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D, Burn Injury
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
cholecalciferol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cholecalciferol
Primary Outcome Measure Information:
Title
calcidiol blood concentration
Time Frame
at the end of the protocol (after one year)
Secondary Outcome Measure Information:
Title
bone health
Description
bone formation and resorption markers (blood concentrations) bone mineral density measurement using dual energy X-ray absorptiometry
Time Frame
at the end of the protocol (after one year)
Title
muscle strength
Description
Measurements of knee muscles strength on an isokinetic dynamometer
Time Frame
at the end of the protocol (after one year)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
occurrence of injury between 2005 and 2011
burn surface area (BSA) greater than 10%
Exclusion Criteria:
Pregnancy, renal or liver failure, hypo or hyperparathyroidism, prior vitamin D substitution, treatment using systemic corticosteroids or antiepileptic drugs, regular exposure to ultraviolet B radiation (solarium), unstable cardiovascular disease or acute muscle or skeletal injury prohibiting physical exercise
Facility Information:
Facility Name
Burn Centre
City
Liège
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Effects of Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period
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