- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00142610
The Role of Vitamins E and C in Maintaining Lung Health in People With Asthma (VITAS)
Effect of Alpha Tocopherol and Ascorbate Supplementation on Airway Antioxidant Levels in Allergic Asthmatics
Panoramica dello studio
Descrizione dettagliata
Eosinophils and neutrophils are inflammatory cells located in the airways and lungs. When they are activated, they generate oxidants, which irritates the mucosal cells in the airways. As a result, mucus develops in the lungs. Allergens can activate the inflammatory cells, thereby worsening the symptoms of asthma in allergic asthmatics. Vitamins E (alpha-tocopherol) and C (ascorbate) have been shown to decrease asthma exacerbation associated with exposure to ozone. Enhancing antioxidant and anti-inflammatory defenses in the airways and lungs is a promising approach for treating respiratory diseases aggravated by allergies. This study will determine if airway antioxidants in allergic asthmatics are enhanced with a combination of vitamin E and vitamin C therapy.
Participants in this double-blind study will be randomly assigned to receive either a combination of alpha-tocopherol and ascorbate or placebo. Treatments will be administered daily for 12 weeks. Baseline assessments will measure airway and circulating antioxidant levels, inflammatory cells, lung function, respiratory symptoms, and methacholine reactivity. Allergy skin tests will also be performed to determine the state of atopy, which is a hereditary predisposition toward developing certain hypersensitivity reactions. Following baseline assessments, lung assessments will be conducted weekly for 12 weeks, sputum and blood samples will be collected bi-weekly, and methacholine reactivity will be assessed at Weeks 6 and 12.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 1
Contatti e Sedi
Luoghi di studio
-
-
North Carolina
-
Chapel Hill, North Carolina, Stati Uniti, 27599
- UNC EPA
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Confirmed 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
- Oxygen saturation greater than 94% at baseline
- Systolic blood pressure between 150 and 90 mm Hg, diastolic blood pressure between 90 and 60 mm Hg
- Physician-diagnosed asthma or history of episodic wheezing, chest tightness, or shortness of breath consistent with asthma
- Airway reactivity as determined by either a provocative concentration of methacholine producing a 20% fall in FEV1 (PC20 methacholine) of less than 10 mg/ml by the method used or 12% reversibility of baseline lung function with albuterol therapy for two of the three measures: FVC, FEV1, and FEF25-75%
- Agree to discontinue use of vitamin supplements for the duration of the study
- On a stable regimen of maintenance asthma therapy that has not changed within the month prior to participation
Exclusion Criteria:
- Chronic medical condition that may make vitamin E and vitamin C treatment medically inadvisable (e.g., significant cardiovascular disease, diabetes requiring medication, chronic kidney disease, chronic thyroid disease, or coagulation defects)
- History of kidney stones
- Use of anticoagulants (e.g., warfarin, heparin, or clopindogrel)
- Pregnant or breastfeeding
- Use of inhaled steroids, cromolyn, or leukotriene inhibitors (Montelukast or Zafirkulast) for at least one month is not criteria for exclusion.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Comparatore placebo: Placebo
|
This is designed as a placebo controlled study of 500 mg alpha tocopherol combined with 2,000 mg of ascorbate, each orally administered daily for 12 weeks, on airway antioxidant levels in asthmatics.
Altri nomi:
|
Sperimentale: vitamin
500 mg alpha tocopherol combined with 2,000 mg of ascorbate, each orally administered daily for 12 weeks
|
This is designed as a placebo controlled study of 500 mg alpha tocopherol combined with 2,000 mg of ascorbate, each orally administered daily for 12 weeks, on airway antioxidant levels in asthmatics.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Sputum cell ascorbate and alpha-tocopherol levels; measured bi-weekly and at Week 12
Lasso di tempo: measurements have been made alalysis still occuring
|
measurements have been made alalysis still occuring
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Methacholine reactivity; measured at Weeks 6 and 12
Lasso di tempo: measure finished, analysis continues
|
measure finished, analysis continues
|
Lung function and symptom scores; measured weekly and at Week 12
Lasso di tempo: measuremet finished, analysis continues
|
measuremet finished, analysis continues
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: David B. Peden, MD, MS, Center for Environmental Medicine, Asthma, and Lung Biology
Pubblicazioni e link utili
Collegamenti utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie delle vie respiratorie
- Malattie del sistema immunitario
- Malattie polmonari
- Ipersensibilità, immediata
- Malattie bronchiali
- Malattie polmonari, ostruttive
- Ipersensibilità respiratoria
- Ipersensibilità
- Asma
- Effetti fisiologici delle droghe
- Meccanismi molecolari dell'azione farmacologica
- Agenti protettivi
- Micronutrienti
- Antiossidanti
- Vitamina E
- Vitamine
Altri numeri di identificazione dello studio
- P01AT002620-02 (Sovvenzione/contratto NIH degli Stati Uniti)
- Project #1
- Grant ID - PO1-AT002620-02
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Vitamin
-
Alcon ResearchCompletato
-
Johns Hopkins UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletatoVitamina D come modificatore dell'epcidina sierica nei bambini con malattia renale cronica (D-fense)Anemia da malattia renale cronicaStati Uniti
-
Aalborg UniversityAalborg University Hospital; CCBR Aalborg A/S, Aalborg, DenmarkCompletatoEmicrania secondo i criteri della International Headache Society (IHS) (ICHD-II)Danimarca
-
Boston Children's HospitalCompletato