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OpenTrials
Completed

NCT Number: NCT02092701

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

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.

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Key information

Conditions

Vitamin D Burn Injury Burns Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Burn Centre

Liège, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

Primary outcomes

  1. calcidiol blood concentration

    Time frame: at the end of the protocol (after one year)

Secondary outcomes

  1. bone health

    Time frame: 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

  2. muscle strength

    Time frame: at the end of the protocol (after one year)

    Measurements of knee muscles strength on an isokinetic dynamometer

Sponsors and collaborators

Lead sponsor

University of Liege

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 20, 2014
Registry last updated
Mar 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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