Burn InjuryPhase 1NCT01413620
Vitamin E Supplementation in Burn Patients
A Phase 1 study testing dl-alpha-tocopheryl acetate in people with Burn Injury, run by Shriners Hospitals for Children at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 months to 85 years
- Conditions the study is for
- Burn Injury
- What is being tested?
- dl-alpha-tocopheryl acetate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 6 months - 85 years
- >20% TBSA burn
Who cannot join
- Bleeding disorders
- Positive hepatitis or HIV screens
- Pregnancy (women)
Trial locations and contacts
1 site in 1 country.
United States1 site
Shriners Hospitals for Children
Galveston, Texas, 77555
About this study
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.
Read the 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 patients. 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 (300-1200 IU RRR-alpha-tocopherol) to burn subjects (n= 20 per group, 6-70 years, ≥20% total body surface burns) for fifteen days. The subjects will be randomly assigned into two groups: an early treatment group who will receive vitamin E for days 1-15 of the study, and a delayed treatment group who will receive vitamin E for days 16-30 of the study. Both groups will be studied for a total of thirty days. 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 patients. 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
- Burn Injury
- Being tested
- dl-alpha-tocopheryl acetate
- Keywords
- Vitamin E, Burn, Oxidation, Lung Dysfunction, Fatty Liver, Lipid Peroxidation
- Medical subject headings
- Burns, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dl-alpha-tocopheryl acetateDrug
Also called Vitamin E, Aqueous Vitamin E Oral Drops, Silarx, No. 54838-0005-30
Ages 6 months-1 year will receive 75 IU/day of dl-alpha-tocopheryl acetate, while ages 2-5 years will receive 150 IU/day. Ages 6-8 will receive 300 IU/day, while ages 9-13 will receive 600 IU/day, ages 14-17 will receive 800 IU/day, and ages 18-70 will receive 1200 IU/day. Vitamin E will be administered 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 may be given in a pill form (Novatol 5-57, No. 410217, Archer Daniels Midland Company, Decatur, IL). Depending on the subject's group, the supplement of vitamin E either will be given on days 1-15 of the study or days 16-30 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E Treated | Experimental | Not described Receives: Drug: dl-alpha-tocopheryl acetate |
| Untreated | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death)
Measured: 30 Days
Gamma-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death)
Measured: 30 Days
Vitamin E Metabolites in Plasma, Urine
Measured: 30 Days
Malondialdehyde in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death)
Measured: 30 Days
Isoprostanes in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death)
Measured: 30 Days
Lipid Panel in Plasma and Triglyceride Concentration
Measured: 30 Days
Liver Ultrasound
Measured: 30 Days
Pulmonary Function Study Variables
Measured: 30 Days
Cardiopulmonary Stress Test
Measured: 30 Days
Secondary outcomes (10)
Open Body Surface Area and Wound Healing
Measured: 30 Days
Weight
Measured: 30 Days
Basal Metabolic Rate
Measured: 30 Days
Diet History and Food Intake
Measured: 30 Days
Fluid Balance
Measured: 30 Days
Incidence of Acute Respiratory Distress Syndrome (ARDS)
Measured: 30 Days
Incidence of Pneumonia
Measured: 30 Days
Incidence of Atelectasis
Measured: 30 Days
Ventilator Variables (Compliance, Resistance, Work of Breathing, Number of Days Ventilated)
Measured: 30 Days
Pulmonary Status Variables (Spirometry, Blood Gas, Diffusion Constant, Pulmonary Capillary Surface Area)
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2017 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shriners Hospitals for Children
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, Oregon State University
- Responsible party
- Principal investigator, Jong O. Lee, Shriners Hospitals for Children
- Investigators
- Jong O Lee, MD, Principal investigator, University of Texas Medical Branch, Shriners Hospitals for ChildrenHal K Hawkins, MD, PhD, Study director, University of Texas Medical Branch, Shriners Hospitals for ChildrenLinda E Sousse, PhD, MBA, Study director, University of Texas Medical Branch, Shriners Hospitals for ChildrenDaniel L Traber, PhD, Study director, University of Texas Medical Branch, Shriners Hospitals for ChildrenMaret G Traber, PhD, Study director, Oregon State UniversityDavid N Herndon, M.D., Study director, University of Texas Medical Branch, Shriners Hospitals for ChildrenCeleste C Finnerty, Ph.D., Study director, University of Texas Medical Branch, Shriners Hospitals for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413620
- Sponsor's protocol ID
- VitE2011
- Status last verified
- Sep 2021
- First submitted
- 9 Aug 2011
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin E Supplementation in Burn Patients
- ClinicalTrials.gov ID
- NCT01413620
- Acronym / sponsor ID
- VitE2011
- Conditions
- Burn Injury
- Keywords
- Vitamin E, Burn, Oxidation, Lung Dysfunction, Fatty Liver, Lipid Peroxidation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Shriners Hospitals for ChildrenUniversity, hospital or other
- Collaborators
- University of Texas, Oregon State University
- Study start
- Aug 2011
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 patients. 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 (300-1200 IU RRR-alpha-tocopherol) to burn subjects (n= 20 per group, 6-70 years, ≥20% total body surface burns) for fifteen days. The subjects will be randomly assigned into two groups: an early treatment group who will receive vitamin E for days 1-15 of the study, and a delayed treatment group who will receive vitamin E for days 16-30 of the study. Both groups will be studied for a total of thirty days. 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 patients. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin E Treated | Experimental | Drug: dl-alpha-tocopheryl acetate |
| Untreated | No intervention | – |
Who may qualify
- Ages
- 6 months to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 6 months - 85 years
- >20% TBSA burn
Key exclusion criteria (3 listed)
- Bleeding disorders
- Positive hepatitis or HIV screens
- Pregnancy (women)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dl-alpha-tocopheryl acetateAlso: Vitamin E, Aqueous Vitamin E Oral Drops, Silarx, No. 54838-0005-30Ages 6 months-1 year will receive 75 IU/day of dl-alpha-tocopheryl acetate, while ages 2-5 years will receive 150 IU/day. Ages 6-8 will receive 300 IU/day, while ages 9-13 will receive 600 IU/day, ages 14-17 will receive 800 IU/day, and ages 18-70 will receive 1200 IU/day. Vitamin E will be administered 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 may be given in a pill form (Novatol 5-57, No. 410217, Archer Daniels Midland Company, Decatur, IL). Depending on the subject's group, the supplement of vitamin E either will be given on days 1-15 of the study or days 16-30 of the study. | Drug | Vitamin E Treated |
Primary outcome
Alpha-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death)
Time frame: 30 Days
Gamma-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death)
Time frame: 30 Days
Vitamin E Metabolites in Plasma, Urine
Time frame: 30 Days
Malondialdehyde in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death)
Time frame: 30 Days
Isoprostanes in Plasma, Urine (also: Lung, Skin, Muscle in the case of Death)
Time frame: 30 Days
Lipid Panel in Plasma and Triglyceride Concentration
Time frame: 30 Days
Liver Ultrasound
Time frame: 30 Days
Pulmonary Function Study Variables
Time frame: 30 Days
Cardiopulmonary Stress Test
Time frame: 30 Days
10 secondary outcomes
Open Body Surface Area and Wound Healing
Time frame: 30 Days
Weight
Time frame: 30 Days
Basal Metabolic Rate
Time frame: 30 Days
Diet History and Food Intake
Time frame: 30 Days
Fluid Balance
Time frame: 30 Days
Incidence of Acute Respiratory Distress Syndrome (ARDS)
Time frame: 30 Days
Incidence of Pneumonia
Time frame: 30 Days
Incidence of Atelectasis
Time frame: 30 Days
Ventilator Variables (Compliance, Resistance, Work of Breathing, Number of Days Ventilated)
Time frame: 30 Days
Pulmonary Status Variables (Spirometry, Blood Gas, Diffusion Constant, Pulmonary Capillary Surface Area)
Time frame: 30 Days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Linda E Sousse, PhD, MBA study director
University of Texas Medical Branch, Shriners Hospitals for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing dl-alpha-tocopheryl acetate in people with Burn Injury, run by Shriners Hospitals for Children at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alpha-Tocopherol in Plasma, Adipose (also: Lung, Skin, Muscle, Liver in the case of Death) (time frame: 30 Days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.