In Vitro Basophil Responsiveness to Allergen Challenge After Gamma-tocopherol Supplementation in Allergic Asthmatics

NCT00836368 | Completed Phase 1

• 2 other identifiers: P01AT002620IRB#08-1884
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: This is a non-masked study with a primary endpoint of in vitro basophil activation by the allergen D. farinae, comparing basophil activation before and after seven days of supplementation. Secondary endpoints will include circulating antioxidant levels (tocopherols and metabolites), in vitro basophil activation to IgG anti-IgE and to N-formyl-methionyl-leucyl-phenylalanine (f-met-leu-phe), and monocyte and basophil responsiveness to in vitro endotoxin challenge. Participants: Twenty allergic asthmatic volunteers Procedures (methods): Volunteers will be given 1200 mg of a gamma tocopherol enriched supplement, a commercially available supplement form of vitamin E. Study participants will undergo assessment of general health, lung function assessment, symptom scoring, and epicutaneous skin test to allergens at baseline and after supplementation. Blood samples will be collected at baseline and after 7 days of gamma-T treatment.

Conditions

Allergic; Asthmatic; Allergy; Asthma

Keywords

Asthma; Asthmatic; Allergy; Allergic; Gamma-tocopherol; Vitamin; Vitamin E

Outcome Measures

Primary Outcomes (1)

• We intend to examine the effect of once daily oral doses 1,200 mg of gamma tocopherol (2 capsules of the gamma tocopherol enriched vitamin E preparation) on in vitro basophil activation with D. farinae challenge.

  7 sdays post gamma-tocopherol treatment

Secondary Outcomes (1)

• Circulating antioxidant levels(tocopherols and metabolites), in-vitro basophil activation to IgG anti-IgE and to N-formyl-methionyl-leucyl-phenylalanine.

  7 days post gamma-tocopherol treatment

Study Arms (1)

MaxiGamma

EXPERIMENTAL

Dietary Supplement: gamma-tocopherol

Interventions

gamma-tocopherol DIETARY_SUPPLEMENT

oral doses 1,200 mg of gamma tocopherol (2 capsules of the gamma tocopherol enriched vitamin E preparation)

Also known as: Vitamin E

MaxiGamma

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \. Specific allergy to House Dust Mite farinae confirmed by positive immediate skin test response.
• \. Oxygen saturation of \> 94 % at baseline 3. Blood pressure within the following parameters (Systolic between 140 - 90, Diastolic between 90-60 mm Hg) 4. Moderate or severe persistent asthma according to NHLBI definitions including history of one of the following:
• Episodic wheezing, chest tightness or shortness of breath consistent with asthma occurring at least once a week that may affect activity
• Asthma symptoms occurring at night or during sleep at least 1 time per week
• measured FEV1 or FVC is \<80% of predicted OR
• 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

You may not qualify if:

• \. Any chronic medical condition considered by the PI as a contraindication to receiving gamma-T, 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.
• \. Non-steroidal Anti-Inflammatory Drugs (NSAIDS) or aspirin (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. 5. Diagnosis of anemia or abnormal blood counts at screening. Abnormal PT or PTT values at screening (PT that is prolonged more than 1-2 sec and PTT prolonged more than 3-5 sec of normal. The normal values used will be those defined by McLendon lab.) 6. 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 10. Use of any tobacco product within the past 6 months 11. Hypertension, classified as a systolic blood pressure of equal to or greater than 140, and a diastolic blood pressure equal to or greater than 90.

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

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Asthma; Hypersensitivity

Interventions

gamma-Tocopherol; Vitamin E

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Michelle Hernandez, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 3, 2009
• First Posted: February 4, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 7, 2011

Record last verified: 2011-11

Locations

US (1)