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