Evaluation of Vitamin D Status in Children With Acute Burns - Full Text View

Evaluation of Vitamin D Status in Children With Acute Burns (VitaminD)

This study is currently recruiting participants.

Verified by Shriners Hospitals for Children, September 2007

First Received: September 25, 2007 Last Updated: September 26, 2007 History of Changes

Sponsored by:	Shriners Hospitals for Children
Information provided by:	Shriners Hospitals for Children
ClinicalTrials.gov Identifier:	NCT00536276

Purpose

To see which vitamin D supplement (D2 vs D3) is most beneficial in burned children.

Condition	Intervention	Phase
Burns Bone Demineralization	Dietary Supplement: Vitamin D2 Dietary Supplement: Vitamin D3	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Vitamin D Deficiency in Acutely Injured Pediatric Burn Patients: Incidence, Etiology, Metabolic Sequelae and Prevention

Resource links provided by NLM:

MedlinePlus related topics: Burns Dietary Supplements Diets

Drug Information available for: Ergocalciferol Cholecalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by Shriners Hospitals for Children:

Primary Outcome Measures:

Examine the effect of D2 vs D3 supplementation on serum 25-OH and 1,25 OH vitamin D levels [ Time Frame: During acute phase postburn ]

Secondary Outcome Measures:

Identify the most efficacious vitamin D analogue in terms of preventing deterioration of bone markers [ Time Frame: During acute phase postburn ]

Estimated Enrollment:	75
Study Start Date:	March 2003
Estimated Study Completion Date:	January 2009

Intervention Details:

Daily enteral dose of 100IU/kg

Detailed Description:

The purpose of this study is to follow up our descriptive observations with a prospective randomized double blinded study to verify our clinical perception that hypovitaminosis D is prevalent postburn and to evaluate whether therapeutic supplementation will enhance specific primary outcome measures during burn convalescence.

Eligibility

Ages Eligible for Study:	6 Months to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Child is > 6 months of age but < 19 years old
Burn injury > 30% total body surface area
Admitted to SHC within 4 days of injury
Attending physician decision that patient is likely to survive
Parents or leagal guardian give informed consent along with assent of the child as applicable

Exclusion Criteria:

Attending physician decision that patient is not likely to survive
Prior history of anticonvulsant or glucocorticoid use, gastric/bowel resection, parathyroid disease, liver disease, chronic renal failure or prior pharmacologic vitamine D use (>1000 IU/D)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536276

Contacts

Contact: Michele M Gottschlich, PhD, RD, CNSD	513-872-6298	mgottschlich@shrinenet.org
Contact: Theresa Mayes, BS, RD	513-872-6043	tmayes@shrinenet.org

Locations

United States, Ohio
Shriners Hospital for Children	Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Michele M Gottschlich, PhD, RD, CNSD 513-872-6298 mgottschlich@shrinenet.org
Contact: Theresa Mayes, BS, RD 513-872-6043 tmayes@shrinenet.org
Principal Investigator: Michele M Gottschlich, PhD, RD, CNSD
Sub-Investigator: Theresa Mayes, BS, RD
Sub-Investigator: Chris Allgeier, DTR
Sub-Investigator: Carmen Brunner, BS, RD
Sub-Investigator: Mary Rieman, BSN
Sub-Investigator: Richard Kagan, MD

Sponsors and Collaborators

Shriners Hospitals for Children

Investigators

Principal Investigator:

Michele M Gottschlich, PhD, RD, CNSD

Shriners Hospital for Children

More Information

Publications:

Gottschlich MM, Mayes T, Khoury J, Warden GD. Hypovitaminosis D in acutely injured pediatric burn patients. J Am Diet Assoc. 2004 Jun;104(6):931-41, quiz 1031.

Study ID Numbers:	01-9-26-1
Study First Received:	September 25, 2007
Last Updated:	September 26, 2007
ClinicalTrials.gov Identifier:	NCT00536276 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Shriners Hospitals for Children:

vitamin D

Study placed in the following topic categories:

Vitamin D Deficiency
Burns
Cholecalciferol
Ergocalciferol
Wounds and Injuries
Ergocalciferols
Disorders of Environmental Origin
Trace Elements

Bone Density Conservation Agents
Vitamin D
Vitamin D2
Vitamin D3
Vitamins
Micronutrients
Calciferol

Additional relevant MeSH terms:

Burns
Cholecalciferol
Vitamin D
Growth Substances
Vitamins
Physiological Effects of Drugs

Ergocalciferols
Wounds and Injuries
Disorders of Environmental Origin
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2009