- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00386178
Safety Study of a Vitamin E Supplement in Normal Volunteers and Those With Both Allergy and Asthma
Comparison of Gamma-tocopherol Supplementation in Allergic Asthmatics and Normal Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is designed as an open label study of the effect of 600 mg and 1200mg gamma tocopherol (gt), orally administered daily for 8 days, on serum antioxidant levels in asthmatics and healthy volunteers. Each course of gamma tocopherol will be followed by a 7-8 day wash out period and serum testing to ensure that blood levels are back to baseline prior to starting the next course. The gamma tocopherol will be obtained from Yasoo Health Inc and contains 623mg gt per 830 mg gelatin capsule.
Allergy skin testing to a battery of allergens common to the region will be performed to determine the state of atopy both prior to drug administration and after the 8 day course. Allergic volunteers will be asked to abstain from taking any antihistamines during the 3 days prior to the skin testing. Repeat allergy testing will not be performed on subjects unable to hold antihistamines for health reasons, or on non-allergic volunteers who demonstrate no response to baseline testing. Spirometry will be performed to determine the current level of lung function. Subjects will be asked to refrain from taking vitamin supplements, non-steroidal anti-inflammatory medications and other dietary supplements.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27599-7310
- Center for Environmental Medicine, Asthma and Lung Biology at the University of North Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: allergic asthmatic cohort
- Specific allergy to at least one of the following allergen preparations: (House Dust Mite f, House dust mite p, Cockroach, Tree mix, Grass Mix, Weed Mix, Mold Mix 1, Mold Mix 2, Rat, Mouse, Guinea Pig, Rabbit, Cat or Dog) confirmed by positive immediate skin test response.
- Oxygen saturation of > 94 % at baseline
- Blood pressure within the following parameters (Systolic between 150 - 90,Diastolic between 100-60 mm Hg)
- Moderate or severe persistent asthma according to NHLBI definitions including history of one of the following: 1)Episodic wheezing, chest tightness or shortness of breath consistent with asthma occurring at least once a week that may affect activity;2)Asthma symptoms occurring at night or during sleep at least 1 time per week; 3)measured FEV1 or FVC is <80% of predicted; OR 4)physician diagnosed moderate or severe persistent asthma which is currently treated or controlled with maintenance medication including moderate or high dose inhaled corticosteroid, or any dose of inhaled corticosteroid and a long-acting inhaled B2-agonist
Inclusion Criteria- healthy volunteer cohort
- Oxygen saturation > 94 % at baseline
- Blood pressure within the following parameters (Systolic between 150 - 90, Diastolic between 100-60 mm Hg)
- No active allergies
- No physician diagnosis of asthma since age 6
Exclusion Criteria:
- Any chronic medical condition considered by the PI as a contraindication to receiving gamma tocopherol, including significant cardiovascular disease, diabetes requiring medication, chronic renal disease, chronic thyroid disease, kidney disease or coagulation defects.
- Use of inhaled steroids, cromolyn or leukotriene inhibitors (montelukast or zafirlukast) which have been used for at least one month are allowed. Patients must be on a stable regimen of maintenance asthma therapy which has not changed in the past month prior to entrance into the study.
- NSAID or ASA use within 48 hours of beginning the study, and inability to suspended use of these medications during the length of the study.
- Use of anticoagulants including warfarin, heparin, or clopidogrel.
- Diagnosis of anemia or abnormal blood counts at screening
- Pregnancy or nursing a baby. As this is a phase I study, the potential risk to a fetus cannot be justified.
- Children will not be included in this study as the potential risk to a growing child cannot be justified.
- Adults age 51 and older are excluded as the potential for concomitant illness in this population increases the risk for confounding the data.
- Known vagal response to venipuncture
- Abnormal PT or PTT values at screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Vitamin E supplement rich in gamma tocopherol
|
daily dose of Vitamin E supplement rich in gamma tocopherol
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
serum levels of gamma tocopherol and its metabolites after eight days of supplementation
Time Frame: eight days
|
eight days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
latency between the first dose and peak levels of gamma tocopherol
Time Frame: levels at points within 24 hours
|
levels at points within 24 hours
|
effect of gamma tocopherol supplementation on other antioxidants
Time Frame: 8 days
|
8 days
|
effect of supplementation with gamma tocopherol on changes on cell surface marker expression on circulating monocytes and macrophages and on these cells' response to ex vivo LPS challenge
Time Frame: 1-8 days
|
1-8 days
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Protective Agents
- Micronutrients
- Vitamins
- Antioxidants
- Vitamin E
- Tocopherols
- alpha-Tocopherol
- Tocotrienols
- gamma-Tocopherol
Other Study ID Numbers
- 05-2833
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SingHealth PolyclinicsNot yet recruitingAsthma | Asthma in Children | Asthma Attack | Asthma Acute | Asthma Chronic
-
Johann Wolfgang Goethe University HospitalCompleted
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain
-
Universita di VeronaCompleted
-
Forest LaboratoriesCompleted
-
Brunel UniversityKarolinska InstitutetUnknown
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
Clinical Trials on Vitamin E supplement rich in gamma tocopherol
-
University of North Carolina, Chapel HillNational Institute of Environmental Health Sciences (NIEHS); Purdue UniversityCompletedMild, Allergic AsthmaUnited States
-
University of North Carolina, Chapel HillCompletedAllergic Rhinitis | Mild AsthmaUnited States
-
University of North Carolina, Chapel HillNational Center for Complementary and Integrative Health (NCCIH)Completed
-
University of North Carolina, Chapel HillNational Institute of Environmental Health Sciences (NIEHS)CompletedGamma Tocopherol Serum LevelsUnited States
-
University of North Carolina, Chapel HillNational Center for Complementary and Integrative Health (NCCIH)CompletedAsthma | Allergy | Asthmatic | AllergicUnited States
-
University of North Carolina, Chapel HillNational Institute of Environmental Health Sciences (NIEHS)CompletedAllergic AsthmaUnited States
-
University of North Carolina, Chapel HillNational Institute of Environmental Health Sciences (NIEHS)CompletedAsthma | Airway InflammationUnited States
-
Oregon Health and Science UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Oregon...TerminatedPeripheral Neuropathy | Mitochondrial Trifunctional Protein DeficiencyUnited States
-
Southwest Oncology GroupNational Cancer Institute (NCI); National Eye Institute (NEI)CompletedMacular Degeneration | CataractUnited States
-
The George Washington University Biostatistics...Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted