Antioxidant Therapy in Lean and Obese Asthmatics (ALOA)
|ClinicalTrials.gov Identifier: NCT01317563|
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : March 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Dietary Supplement: Vitamins A, E, C & Selenium Dietary Supplement: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase 2 Study of Antioxidant Therapy in Lean and Obese Asthmatics|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||March 2016|
Active Comparator: Antioxidant arm
Two capsules twice daily (total daily dose = Vitamin A 10000 IU, Vitamin C 1200mg, Vitamin E 400 IU, Selenium 300mcg)
Dietary Supplement: Vitamins A, E, C & Selenium
daily dose = Vitamin A 10000 IU (beta carotene), Vitamin E 400 IU, Vitamin C 1200mg, and Selenium 300mcg.
Placebo Comparator: Placebo arm
two capsules twice daily (total daily dose = 1200mg whey protein, 800mg microcrystalline cellulose)
Dietary Supplement: Placebo
total daily dose = 1200mg whey protein, 800mg microcrystalline cellulose
- Change in Asthma Control Questionnaire (Juniper)- (ACQ) [ Time Frame: 6 weeks ]ACQ is a 7 component test that includes 6 responses elliciting control of asthma symptoms plus one component based on FEV1 (spirometry). The score ranges from 0-6, with a higher score suggesting greater asthma symptoms.
- Change in Asthma Symptom Utility Index [ Time Frame: 6 weeks ]Questionnaire assessing patient reported asthma symptoms from the previous 2 weeks. Score ranges from 0 to 1 with a higher score suggesting better asthma control.
- change in FEV1 [ Time Frame: 6 weeks ]Spirometric measure of volume expired in 1 second.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317563
|United States, Florida|
|Nemours Children's Clinic|
|Jacksonville, Florida, United States, 32207|
|Principal Investigator:||Jason E Lang, M.D.||Nemours Children's Clinic|