NCT02092701

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
Last Updated

March 20, 2014

Status Verified

March 1, 2014

Enrollment Period

1 year

First QC Date

March 17, 2014

Last Update Submit

March 18, 2014

Conditions

Vitamin DBurn Injury

Outcome Measures

Primary Outcomes (1)

  • calcidiol blood concentration

    at the end of the protocol (after one year)

Secondary Outcomes (2)

  • bone health

    at the end of the protocol (after one year)

  • muscle strength

    at the end of the protocol (after one year)

Study Arms (1)

cholecalciferol

EXPERIMENTAL
Drug: Cholecalciferol

Interventions

CholecalciferolDRUG
cholecalciferol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • occurrence of injury between 2005 and 2011
  • burn surface area (BSA) greater than 10%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burn Centre

Liège, Belgium

Location

MeSH Terms

Conditions

Burns

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 20, 2014

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

March 20, 2014

Record last verified: 2014-03

Locations

BE(1)