Antioxidant Therapy in Lean and Obese Asthmatics

Asthma Clinical Trial

— ALOA  

Official title:

Phase 2 Study of Antioxidant Therapy in Lean and Obese Asthmatics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01317563
• Other study ID #: ALASE08140ALOA
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2011
• Last updated: March 21, 2016
• Start date: July 2008
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This project will assess the effectiveness of antioxidant supplementation with common vitamins A, C, E and selenium in controlling asthma symptoms among lean and obese asthmatics. This project may improve our ability to treat asthma and our understanding of the link between nutritional antioxidants and asthma.

Description:

Asthma & Obesity are both growing public health crises that also may be critically interrelated for many patients. Obesity increases the risk for asthma in both adults and children, and obesity increases the severity of existing asthma. Obesity leads to increased systemic oxidative stress, however little is know about obesity-related oxidative stress within the airway. Since oxidative stress contributes to the pathogenesis of asthma, obesity may influence asthma risk and severity through this mechanism. Asthmatics have low serum antioxidant activity. There is conflicting evidence about whether or not antioxidant supplementation reduces asthma severity. This may be related to asthma's heterogeneous nature. Antioxidant supplementation may be effective in select subgroups that have the greater oxidative stress, such as asthmatics with occupational exposures or obesity. In fact, the evidence supporting antioxidant supplementation in asthma involved subjects with oxidant-related triggers. We hypothesize that obesity-related oxidant stress puts asthmatics at risk for increased airway oxidative stress and greater asthma severity. We hypothesize that supplementation with common antioxidants will significantly reduce airway inflammation and oxidative stress, and lead to improved pulmonary function and daily asthma control. This pilot study is designed as a randomized, double-blinded, placebo-controlled, parallel intervention trial involving lean and obese adolescents and young adults with asthma. After the 2-week run-in period, all subjects will undergo baseline testing (see figure 1). At randomization they will receive either placebo or a multivitamin antioxidant for 42 days. At the end of the 42 day intervention all subjects will undergo final testing. Primary Hypothesis: In young asthmatics, antioxidant supplementation increases plasma and airway antioxidant levels leading to improved lung function and asthma control. Secondary Hypotheses: 1) Obesity-related systemic oxidant stress is associated with increased oxidative stress within the airway. 2) Antioxidant supplementation will lead to greater improvements in asthma control among obese compared to lean (not underweight) asthmatics. 3) Antioxidant supplementation will lead to greater improvements in airway markers of inflammation and oxidative stress among obese compared to lean asthmatics. We will assess asthma control and lung function before and after therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: March 2016
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 25 Years

Eligibility

Inclusion Criteria:

• age 12-25,

• physician-diagnosed persistent asthma on daily controller therapy,

• FEV1% >= 60% predicted,

• Lung responsiveness (>= 12% BD reversibility or PC20 MCT <= 16mg/ml)

Exclusion Criteria:

• taking daily MVI,

• chronic oral steroid therapy,

• BMI<20th percentile,

• smoking history,

• pregnancy,

• milk allergy,

• celiac disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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
total daily dose = 1200mg whey protein, 800mg microcrystalline cellulose

Locations

Country	Name	City	State
United States	Nemours Children's Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Nemours Children's Clinic	American Lung Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Asthma Control Questionnaire (Juniper)- (ACQ)	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.	6 weeks	No
Secondary	Change in Asthma Symptom Utility Index	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.	6 weeks	Yes
Secondary	change in FEV1	Spirometric measure of volume expired in 1 second.	6 weeks	No