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

NCT ID: NCT02092701

Last Updated: 2014-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-10-31

Brief Summary

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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

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Conditions

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Vitamin D Burn Injury

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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cholecalciferol

Group Type EXPERIMENTAL

Cholecalciferol

Intervention Type DRUG

Interventions

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Cholecalciferol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Liege

OTHER

Sponsor Role lead

Responsible Party

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Rousseau

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Burn Centre

Liège, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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HDB1

Identifier Type: -

Identifier Source: org_study_id

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