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

NCT00386178 | Completed Phase 1

• 1 other identifier: 05-2833
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

vitamin E; gamma tocopherol; moderate to severe asthma; healthy subjects

Outcome Measures

Primary Outcomes (1)

• serum levels of gamma tocopherol and its metabolites after eight days of supplementation

  eight days

Secondary Outcomes (3)

• latency between the first dose and peak levels of gamma tocopherol

  levels at points within 24 hours

• effect of gamma tocopherol supplementation on other antioxidants

  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

  1-8 days

Study Arms (1)

1

EXPERIMENTAL

Vitamin E supplement rich in gamma tocopherol

Drug: Vitamin E supplement rich in gamma tocopherol

Interventions

Vitamin E supplement rich in gamma tocopherol DRUG

daily dose of Vitamin E supplement rich in gamma tocopherol

Also known as: Maxi-Gamma

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Center for Environmental Medicine, Asthma and Lung Biology at the University of North Carolina

Chapel Hill, North Carolina, 27599-7310, United States

Location

Related Links

• Center for Environmental Medicine, Asthma and Lung Biology

MeSH Terms

Conditions

Asthma

Interventions

gamma-Tocopherol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tocopherols; Vitamin E; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• David B Peden, MD, MS

  University of North Carolina at Chapel Hill, Dept of Pediatrics / Center for Environmental Medicine, Asthma and Lung Biology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 11, 2006
• Study Start: October 1, 2006
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: December 21, 2010

Record last verified: 2010-12

Locations

US (1)