Antioxidant Therapy in Lean and Obese Asthmatics

NCT01317563 | Completed Phase 2

• 1 other identifier: ALASE08140ALOA
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

asthma; obesity; nutrition; antioxidant

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in Asthma Symptom Utility Index

  6 weeks

• change in FEV1

  6 weeks

Study Arms (2)

Antioxidant arm

ACTIVE COMPARATOR

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

Placebo arm

PLACEBO COMPARATOR

two capsules twice daily (total daily dose = 1200mg whey protein, 800mg microcrystalline cellulose)

Dietary Supplement: Placebo

Interventions

Vitamins A, E, C & Selenium DIETARY_SUPPLEMENT

daily dose = Vitamin A 10000 IU (beta carotene), Vitamin E 400 IU, Vitamin C 1200mg, and Selenium 300mcg.

Antioxidant arm

Placebo DIETARY_SUPPLEMENT

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

Placebo arm

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• age 12-25,
• physician-diagnosed persistent asthma on daily controller therapy,
• FEV1% \>= 60% predicted,
• Lung responsiveness (\>= 12% BD reversibility or PC20 MCT \<= 16mg/ml)

You may not qualify if:

• taking daily MVI,
• chronic oral steroid therapy,
• BMI\<20th percentile,
• smoking history,
• pregnancy,
• milk allergy,
• celiac disease

Sponsors & Collaborators

• Nemours Children's Clinic: lead
• American Lung Association: collaborator

Study Sites (1)

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Asthma; Obesity

Interventions

Selenium

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Minerals

Study Officials

• Jason E Lang, M.D.

  Nemours Children's Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: March 17, 2011
• Study Start: July 1, 2008
• Primary Completion: June 1, 2012
• Study Completion: March 1, 2016
• Last Updated: March 22, 2016

Record last verified: 2016-03

Locations

US (1)