Clinical trial NCT01317563: Antioxidant Therapy in Lean and Obese Asthmatics
Official title: Phase 2 Study of Antioxidant Therapy in Lean and Obese Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: asthma
obesity
nutrition
antioxidant
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: American Lung Association
First posted: 2011-03-17
Enrollment: 43
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Asthma Control Questionnaire (Juniper)- (ACQ)
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Asthma Symptom Utility Index
timeFrame: 6 weeks
measure: change in FEV1
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
Study officials:
affiliation: Nemours Children's Clinic
name: Jason E Lang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: