Antioxidant Therapy in Lean and Obese Asthmatics (ALOA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Nemours Children's Clinic.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
American Lung Association
Information provided by:
Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT01317563
First received: March 16, 2011
Last updated: July 25, 2011
Last verified: March 2011
  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

Resource links provided by NLM:


Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01317563

Locations
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
American Lung Association
Investigators
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 July 22, 2014