History of Changes for Study: NCT01413620

Vitamin E Supplementation in Pediatric Burn Patients

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Study Record Versions

Version	Submitted Date	Changes
1	August 9, 2011	None (earliest Version on record)
2	March 10, 2012	Recruitment Status, Sponsor/Collaborators, Study Status, Contacts/Locations, Outcome Measures, Arms and Interventions, Eligibility, Study Identification, Study Design, Study Description and Oversight
3	August 17, 2016	Study Status, Contacts/Locations, Eligibility, Arms and Interventions, IPDSharing, Study Design and Oversight
4	September 20, 2021	Recruitment Status, Study Status, Contacts/Locations and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	VitE2011
Brief Title:	Vitamin E Supplementation in Pediatric Burn Patients
Official Title:	Vitamin E Supplementation in Pediatric Burn Patients
Secondary IDs:

Study Status


Record Verification:	August 2011
Overall Status:	Not yet recruiting
Study Start:	October 2011
Primary Completion:	April 2013 [Anticipated]
Study Completion:	October 2013 [Anticipated]

First Submitted:	August 9, 2011
First Submitted that Met QC Criteria:	August 9, 2011
First Posted:	August 10, 2011 [Estimate]

Last Update Submitted that Met QC Criteria:	August 9, 2011
Last Update Posted:	August 10, 2011 [Estimate]

Sponsor/Collaborators


Sponsor:	Shriners Hospitals for Children
Responsible Party:
Collaborators:	University of Texas Oregon State University

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

Study Description

Brief Summary:

Burned patients because of their increased oxidative stress have severely depleted vitamin E, which is a dietary antioxidant. Oxidative stress is responsible for much of the pathophysiology seen in burned patients, which leads to acute and chronic morbidity and mortality, in addition to a decrease in their quality of life. Oral vitamin E will be used to reverse the oxidative stress of burn injury and, in the process, decrease the secondary consequences of thermal trauma. This proposal will demonstrate the benefit of maintaining adequate vitamin E status.

Detailed Description:

We have previously demonstrated that thermal injury depletes plasma vitamin E in pediatric burn patients. However, plasma changes reflect short-term vitamin E changes, whereas adipose tissue alpha-tocopherol concentrations reflect long-term vitamin E status. We reported last year that burn injury depleted vitamin E stores in adipose tissue in children by nearly half within one month following injury. Our long-term goal is to improve the quality of life of burn patients by preventing pulmonary and hepatic dysfunction that may occur from vitamin E depletion. The objectives of this application are to a) attenuate alpha-tocopherol depletion in burned patients by vitamin E supplementation, b) prevent or reverse oxidative stress in these patients, and c) collect pilot data on the effect of vitamin E supplementation on lung and liver function. Our central hypothesis is that the administration of high doses of alpha-tocopherol will prevent or restore levels of vitamin E in adipose tissue and reverse the oxidative state in burned children. The rationale of the proposed studies is that in severe cases of vitamin E depletion, oxidative stress, fatty liver and lung dysfunction have all been reported in our patients. We will administer vitamin E supplements (800 mg RRR-alpha-tocopherol) to pediatric burn subjects (n= 20 per group, 6-17 years, 20-30% total body surface burns) daily for four weeks and compare them to a control group of matched pediatric burn subjects. We will test the following aims: Aim 1: determine the degree that supplemental Vitamin E will attenuate alpha-tocopherol depletion. Aim 2: determine if supplemental Vitamin E reduces markers of oxidative stress in burned children. Aim 3: collect preliminary data to establish the relationship between oxidative stress and pulmonary pathophysiology and fatty liver after burn injury. We will measure plasma and adipose tissue alpha-tocopherol and urinary and plasma markers of oxidative stress, prior to supplementation and then weekly. The proposed research is innovative because the oxidative stress of burn injury causes a severe depletion of an essential nutrient, vitamin E. Supplementation of vitamin E is a novel concept that may mitigate the complications of burns, including lung injury, fatty liver and peripheral neuropathy.

Conditions


Conditions:	Burn Injury
Keywords:	Vitamin E Burn Oxidation Lung Dysfunction Fatty Liver Lipid Peroxidation

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	Single (Participant)
Allocation:	Randomized
Enrollment:	60 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Experimental: Vitamin E Treated

Dietary Supplement: Alpha-Tocopherol

Ages 6-8 will receive 300 mg/day, while ages 9-13 will receive 600 mg/day and ages 14-17 will receive 800 mg/day. Vitamin E will be administered at roughly the same time every morning in a liquid or pill form. The dose of aqueous vitamin E (Aqueous Vitamin E Oral Drops, Silarx, No. 54838-0005-30, Spring Valley, NY) will be given orally. When/If the patient is able to eat independently, the dose of vitamin E will be given in a pill form (Novatol 5-57, No. 410217, Archer Daniels Midland Company, Decatur, IL). The supplement of vitamin E will be given on a daily basis each morning to the vitamin E group for the duration of the study, which is 28 days.

Other Names:

Vitamin E

No Intervention: Untreated

Outcome Measures


Primary Outcome Measures:
1.	Alpha-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death) [ Time Frame: 28 Days ]
2.	Gamma-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death) [ Time Frame: 28 Days ]
3.	Vitamin E Metabolites in Plasma, Urine [ Time Frame: 28 Days ]
4.	Malondialdehyde in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death) [ Time Frame: 28 Days ]
5.	Isoprostanes in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death) [ Time Frame: 28 Days ]
6.	Lipid Panel in Plasma [ Time Frame: 28 Days ]
7.	Triglyceride Concentration [ Time Frame: 28 Days ]
8.	Pulmonary Function Study Variables [ Time Frame: 28 Days ]
9.	Cardiopulmonary Stress Test [ Time Frame: 28 Days ]
Secondary Outcome Measures:
1.	Open Body Surface Area [ Time Frame: 28 Days ]
2.	Weight [ Time Frame: 28 Days ]
3.	Basal Metabolic Rate [ Time Frame: 28 Days ]
4.	Diet History and Food Intake [ Time Frame: 28 Days ]
5.	Fluid Balance [ Time Frame: 28 Days ]
6.	Incidence of Acute Respiratory Distress Syndrome (ARDS) [ Time Frame: 28 Days ]
7.	Incidence of Pneumonia [ Time Frame: 28 Days ]
8.	Incidence of Atelectasis [ Time Frame: 28 Days ]
9.	Ventilator Variables (Compliance, Resistance, Work of Breathing, Number of Days Ventilated) [ Time Frame: 28 Days ]
10.	Pulmonary Status Variables (Spirometry, Blood Gas, Diffusion Constant, Pulmonary Capillary Surface Area) [ Time Frame: 28 Days ]

Eligibility


Minimum Age:	6 Years
Maximum Age:	17 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: Age: 6 - 17 years 20-30% TBSA burn Exclusion Criteria: Septic shock Bleeding disorders Diabetes, or on diabetes medications or anti-lipidemic agents Known liver disease, other than hepatic steatosis Kidney/renal disease, endocrine disease, cancer, heart disease, osteoporosis Congestive heart failure Alcohol abuse (>20 g/day; CAGE questionnaire) or drug abuse (amphetamines, cocaine, opioids, marijuana) Positive hepatitis or HIV screens Pregnancy (women)

Contacts/Locations


Central Contact Person:	Jong O Lee, MD Telephone: (409) 770-6731 Email: jolee@utmb.edu
Central Contact Backup:	Linda E Sousse, PhD, MBA Telephone: (409) 772-6458 Email: lesousse@utmb.edu
Study Officials:	Jong O Lee, MD Principal Investigator University of Texas Medical Branch, Shriners Hospitals for Children
	Hal K Hawkins, MD, PhD Study Director University of Texas Medical Branch, Shriners Hospitals for Children
	Labros S Sidossis, PhD Study Director University of Texas Medical Branch, Shriners Hospitals for Children
	Linda E Sousse, PhD, MBA Study Director University of Texas Medical Branch, Shriners Hospitals for Children
	Daniel L Traber, PhD Study Director University of Texas Medical Branch, Shriners Hospitals for Children
	Maret G Traber, PhD Study Director Oregon State University
Locations:	United States, Texas
	Shriners Hospitals for Children Galveston, Texas, United States, 77555 Contact:Contact: Deb Benjamin, RN 409-772-3622 dbenjami@UTMB.EDU Contact:Principal Investigator: Jong O Lee, MD

IPDSharing


Plan to Share IPD:

References


Citations:
Links:
Available IPD/Information: