Fish Oil and Asthma in House Dust Mite Allergy

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00380926
First received: September 25, 2006
Last updated: September 28, 2006
Last verified: September 2006
  Purpose

Native populations consuming high amounts of fish suffer less from allergic diseases. The purpose of this study is to determine whether polyunsaturated fatty acids (fish oil) might have a disease modifying influence on asthmatics sensitized to house dust mite.


Condition Intervention Phase
Allergic Asthma
Bronchial Inflammation
House Dust Mite Allergy
Drug: polyunsatturated fatty acids (fish oil)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Anti-Inflammatory Effect of Polyunsaturated Fatty Acids in Allergic Asthma After Allergen Challenge

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • lung function, symptom score,exhalative nitric oxide, metacholine testing

Secondary Outcome Measures:
  • sulfoleucotriens, eosinophilic cationic protein, sputum eosinophils, safety lab parameters (clinical chemistry, hematology, hemostasis)

Estimated Enrollment: 23
Study Start Date: April 2004
Estimated Study Completion Date: November 2004
Detailed Description:

Most asthmatics suffer from mild disease and non pharmacologic intervention would be beneficial for the majority of these subjects. We investigated the anti-inflammatory potential of polyunsaturated fatty acids (PUFA) in allergic asthma.

In our parallel, double-blinded study, 23 patients allergic to house dust mite were randomly assigned to dietary supplementation with a PUFA enriched fat blend or placebo for five weeks. The verum contained eicosapentaenoic acid (EPA) 450 mg/day, docosahexaenoic acid 180 mg/day, stearidonic acid 60mg/day, and gamma-linolenic acid 60 mg/day; the placebo consisted of mainly unsaturated and monosaturated fatty acids. After three weeks, the patients were challenged with low doses of inhalative house dust mite allergen for two weeks.

Following parameters were determined during low-dose allergen exposure in both groups: exhaled NO (eNO) as a marker of bronchial inflammation, clinical symptoms, FEV1, beta-agonist usage, and bronchial hyperreactivity, sputum eosinophils and sulfoleucotrienes. Compliance with the study protocol was controlled by the determination of PUFAs in plasma and erythrocytes.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • allergic sensitization to house dust mite as proven by skin test and specific IgE
  • normal lung function, episodic asthma

Exclusion Criteria:

  • history of hypersensitization towards fish oil, chronic illness, pregnancy
  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: NCT00380926

Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Prof. Stefan Zielen, M.D. Goethe University, Dpt of Pulmonology/Allergy
  More Information

Publications:
Horrobin DF. Low prevalences of coronary heart disease (CHD), psoriasis, asthma and rheumatoid arthritis in Eskimos: are they caused by high dietary intake of eicosapentaenoic acid (EPA), a genetic variation of essential fatty acid (EFA) metabolism or a combination of both? Med Hypotheses. 1987; 22(4):421-8. Stephensen CB. Fish oil and inflammatory disease: is asthma the next target for n-3 fatty acid supplements? Nutr Rev 2004; 62:486-489 Woods RK, Thien FC, Abramson MJ. Dietary marine fatty acids (fish oil) for asthma in adults and children. Cochrane Database Syst Rev2002; CD001283 Dry J, Vincent D. Effect of a fish oil diet on asthma: results of a 1-year double-blind study. Int Arch Allergy Appl Immunol 1991; 95:156-157 Stenius-Aarniala B, Aro A, Hakulinen A, Ahola I, Seppala E, Vapaatalo H. Evening primrose oil and fish oil are ineffective as supplementary treatment of bronchial asthma. Ann Allergy 1989; 62:534-537 Mickleborough TD, Lindley MR, Ionescu AA, Fly AD. Protective effect of fish oil supplementation on exercise-induced bronchoconstriction in asthma. Chest 2006; 129:39-49

ClinicalTrials.gov Identifier: NCT00380926     History of Changes
Other Study ID Numbers: ZAFES-2004-07
Study First Received: September 25, 2006
Last Updated: September 28, 2006
Health Authority: Germany: Federal Ministry of Food, Agriculture and Consumer Protection

Keywords provided by Johann Wolfgang Goethe University Hospitals:
polyunsatturated fatty acids
nutrition
low-dose allergen challenge
exhaled nitric oxide

Additional relevant MeSH terms:
Asthma
Inflammation
Hypersensitivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014