NCT00380926

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2004

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
Last Updated

September 29, 2006

Status Verified

September 1, 2006

First QC Date

September 25, 2006

Last Update Submit

September 28, 2006

Conditions

Keywords

polyunsatturated fatty acidsnutritionlow-dose allergen challengeexhaled nitric oxide

Outcome Measures

Primary Outcomes (1)

  • lung function, symptom score,exhalative nitric oxide, metacholine testing

Secondary Outcomes (1)

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

Interventions

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Dust Mite Allergy

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, PerennialRhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Officials

  • Prof. Stefan Zielen, M.D.

    Goethe University, Dpt of Pulmonology/Allergy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 27, 2006

Study Start

April 1, 2004

Study Completion

November 1, 2004

Last Updated

September 29, 2006

Record last verified: 2006-09