Effects of Cholecalciferol Supplementation on Bone Health and Muscle Strength in Adults During Post-burn Period

Not Applicable

Completed

• Conditions: Burn Injury; Vitamin D
• Interventions: Drug: Cholecalciferol

• Registration Number: NCT02092701
• Lead Sponsor: University of Liege

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2014-03
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-18
• Last Update Submitted: 2014-03-18
• Study First Posted: 2014-03-20
• Last Update Posted: 2014-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cholecalciferol	Cholecalciferol	-

Primary Outcome Measures

Name	Time	Method
calcidiol blood concentration	at the end of the protocol (after one year)

Secondary Outcome Measures

Name	Time	Method
muscle strength	at the end of the protocol (after one year)	Measurements of knee muscles strength on an isokinetic dynamometer
bone health	at the end of the protocol (after one year)	bone formation and resorption markers (blood concentrations) bone mineral density measurement using dual energy X-ray absorptiometry

Trial Locations

Locations (1)

Burn Centre; 🇧🇪 Liège, Belgium