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

Burn Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02092701
• Other study ID #: HDB1
• Status: Completed
• Phase: N/A
• First received: March 17, 2014
• Last updated: March 18, 2014
• Start date: October 2012
• Est. completion date: October 2013

Study information

• Verified date: March 2014
• Source: University Hospital of Liege
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Burn Injury
• Burns
• Vitamin D

Intervention

Drug:
• Cholecalciferol

Locations

Country	Name	City	State
Belgium	Burn Centre	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	calcidiol blood concentration		at the end of the protocol (after one year)	Yes
Secondary	bone health	bone formation and resorption markers (blood concentrations) bone mineral density measurement using dual energy X-ray absorptiometry	at the end of the protocol (after one year)	No
Secondary	muscle strength	Measurements of knee muscles strength on an isokinetic dynamometer	at the end of the protocol (after one year)	No