Antioxidant Therapy in Lean and Obese Asthmatics (ALOA)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamins A, E, C & Selenium
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring asthma, obesity, nutrition, antioxidant
Eligibility Criteria
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
Sites / Locations
- Nemours Children's Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Antioxidant arm
Placebo arm
Arm Description
Two capsules twice daily (total daily dose = Vitamin A 10000 IU, Vitamin C 1200mg, Vitamin E 400 IU, Selenium 300mcg)
two capsules twice daily (total daily dose = 1200mg whey protein, 800mg microcrystalline cellulose)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
change in FEV1
Spirometric measure of volume expired in 1 second.
Full Information
NCT ID
NCT01317563
First Posted
March 16, 2011
Last Updated
March 21, 2016
Sponsor
Nemours Children's Clinic
Collaborators
American Lung Association
1. Study Identification
Unique Protocol Identification Number
NCT01317563
Brief Title
Antioxidant Therapy in Lean and Obese Asthmatics
Acronym
ALOA
Official Title
Phase 2 Study of Antioxidant Therapy in Lean and Obese Asthmatics
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic
Collaborators
American Lung Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
asthma, obesity, nutrition, antioxidant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Antioxidant arm
Arm Type
Active Comparator
Arm Description
Two capsules twice daily (total daily dose = Vitamin A 10000 IU, Vitamin C 1200mg, Vitamin E 400 IU, Selenium 300mcg)
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm Description
two capsules twice daily (total daily dose = 1200mg whey protein, 800mg microcrystalline cellulose)
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamins A, E, C & Selenium
Intervention Description
daily dose = Vitamin A 10000 IU (beta carotene), Vitamin E 400 IU, Vitamin C 1200mg, and Selenium 300mcg.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
total daily dose = 1200mg whey protein, 800mg microcrystalline cellulose
Primary Outcome Measure Information:
Title
Change in Asthma Control Questionnaire (Juniper)- (ACQ)
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Change in Asthma Symptom Utility Index
Description
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.
Time Frame
6 weeks
Title
change in FEV1
Description
Spirometric measure of volume expired in 1 second.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason E Lang, M.D.
Organizational Affiliation
Nemours Children's Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Antioxidant Therapy in Lean and Obese Asthmatics
We'll reach out to this number within 24 hrs