Antioxidant Therapy in Lean and Obese Asthmatics (ALOA)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Dietary Supplement: Vitamins A, E, C & Selenium Dietary Supplement: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase 2 Study of Antioxidant Therapy in Lean and Obese Asthmatics |
- Change in Asthma Control Questionnaire (Juniper)- (ACQ) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]Spirometric measure of volume expired in 1 second.
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | 12 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Florida | |
| Nemours Children's Clinic | |
| Jacksonville, Florida, United States, 32207 | |
| Principal Investigator: | Jason E Lang, M.D. | Nemours Children's Clinic |
More Information
No publications provided
| Responsible Party: | Jason E. Lang, M.D., Nemours Children's Clinic |
| ClinicalTrials.gov Identifier: | NCT01317563 History of Changes |
| Other Study ID Numbers: | ALASE08140ALOA |
| Study First Received: | March 16, 2011 |
| Last Updated: | July 25, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Nemours Children's Clinic:
|
asthma obesity nutrition antioxidant |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Antioxidants Selenium Retinol palmitate |
Vitamin A Vitamins Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Trace Elements Micronutrients Growth Substances Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013