Vitamin E Supplementation in Burn Patients
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ClinicalTrials.gov Identifier: NCT01413620 |
Recruitment Status :
Withdrawn
First Posted : August 10, 2011
Last Update Posted : September 21, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Burn Injury | Drug: dl-alpha-tocopheryl acetate | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Vitamin E Supplementation in Burn Patients |
Study Start Date : | August 2011 |
Estimated Primary Completion Date : | August 2017 |
Estimated Study Completion Date : | August 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: Vitamin E Treated |
Drug: dl-alpha-tocopheryl acetate
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.
Other Names:
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No Intervention: Untreated |
- 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 ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 6 Months to 85 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age: 6 months - 85 years
- >20% TBSA burn
Exclusion Criteria:
- Bleeding disorders
- Positive hepatitis or HIV screens
- Pregnancy (women)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413620
United States, Texas | |
Shriners Hospitals for Children | |
Galveston, Texas, United States, 77555 |
Principal Investigator: | Jong O Lee, MD | University of Texas Medical Branch, Shriners Hospitals for Children | |
Study Director: | Hal K Hawkins, MD, PhD | University of Texas Medical Branch, Shriners Hospitals for Children | |
Study Director: | Linda E Sousse, PhD, MBA | University of Texas Medical Branch, Shriners Hospitals for Children | |
Study Director: | Daniel L Traber, PhD | University of Texas Medical Branch, Shriners Hospitals for Children | |
Study Director: | Maret G Traber, PhD | Oregon State University | |
Study Director: | David N Herndon, M.D. | University of Texas Medical Branch, Shriners Hospitals for Children | |
Study Director: | Celeste C Finnerty, Ph.D. | University of Texas Medical Branch, Shriners Hospitals for Children |
Responsible Party: | Jong O. Lee, Assistant Professor of Surgery and Faculty Surgeon, Shriners Hospitals for Children |
ClinicalTrials.gov Identifier: | NCT01413620 |
Other Study ID Numbers: |
VitE2011 |
First Posted: | August 10, 2011 Key Record Dates |
Last Update Posted: | September 21, 2021 |
Last Verified: | September 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Vitamin E Burn Oxidation |
Lung Dysfunction Fatty Liver Lipid Peroxidation |
Burns Wounds and Injuries Vitamins Vitamin E Tocopherols Tocotrienols |
alpha-Tocopherol Micronutrients Physiological Effects of Drugs Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents |