Safety Study of a Vitamin E Supplement in Normal Volunteers and Those With Both Allergy and Asthma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT00386178
First received: October 6, 2006
Last updated: December 20, 2010
Last verified: December 2010
  Purpose

Gamma tocopherol (gt) is a naturally occurring form of vitamin E that is found in many foods, and is also commercially available as a vitamin supplement. The purpose of this Phase 1 research study is to see if two doses of gt, 600mg and 1200mg, are safe (do not cause gastrointestinal distress or other problems), and can cause changes in your blood levels of gt and other antioxidants. This study will also examine if there is a difference in response between asthmatic and non-asthmatic adults when taking the same dose of gt. Phase 1 research studies like this one are not intended to be a treatment, but are a scientific investigation.


Condition Intervention Phase
Asthma
Drug: Vitamin E supplement rich in gamma tocopherol
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Comparison of Gamma-tocopherol Supplementation in Allergic Asthmatics and Normal Volunteers

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • serum levels of gamma tocopherol and its metabolites after eight days of supplementation [ Time Frame: eight days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • latency between the first dose and peak levels of gamma tocopherol [ Time Frame: levels at points within 24 hours ] [ Designated as safety issue: No ]
  • effect of gamma tocopherol supplementation on other antioxidants [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: October 2006
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Vitamin E supplement rich in gamma tocopherol
Drug: Vitamin E supplement rich in gamma tocopherol
daily dose of Vitamin E supplement rich in gamma tocopherol
Other Name: Maxi-Gamma

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00386178

Locations
United States, North Carolina
Center for Environmental Medicine, Asthma and Lung Biology at the University of North Carolina
Chapel Hill, North Carolina, United States, 27599-7310
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: David B Peden, MD, MS University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology
  More Information

Additional Information:
No publications provided

Responsible Party: David Peden, MD/Principal Investigator, UNC Center for Environmental Medicine
ClinicalTrials.gov Identifier: NCT00386178     History of Changes
Other Study ID Numbers: 05-2833
Study First Received: October 6, 2006
Last Updated: December 20, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
vitamin E
gamma tocopherol
moderate to severe asthma
healthy subjects

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Gamma-Tocopherol
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Vitamins
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 29, 2014