Effects of Cholecalciferol Supplementation on Bone Health... | NCT02092701

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

NCT02092701

Sponsor

University of Liege

Status

Completed

Last Update Posted

Mar 20, 2014Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Vitamin D
Burn Injury

Interventions

Cholecalciferol

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Oct 2013Actual

Completion Date

Oct 2013Actual

First Submitted Date

Mar 17, 2014

First Submission Date that Met QC Criteria

Mar 18, 2014

First Posted Date

Mar 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2014

Last Update Posted Date

Mar 20, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
cholecalciferol	Experimental		Drug: Cholecalciferol

Name	Type	Description	Arm Group Labels	Other Names
Cholecalciferol	Drug		cholecalciferol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
calcidiol blood concentration		at the end of the protocol (after one year)

Secondary Outcomes

Measure	Description	Time Frame
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)
muscle strength

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D002056	Burns

ID	Term
D014947	Wounds and Injuries

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided