- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00519740
Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen
February 3, 2009 updated by: Johann Wolfgang Goethe University Hospital
Influence of Nutrition on Nasal and Bronchial Affliction in Patients With Allergy on Grass-Pollen After Low-Dosed Specific Bronchial Provocation
The study is meant to observe the influence of nutrition on nasal and bronchial discomfort in patients with allergy on grass pollen after specific bronchial provocation.
Therefore, the investigators will record the patients' nutrition habits and measure the blood level of long chained polyunsaturated fatty-acids.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hessen
-
Frankfurt, Hessen, Germany, 60590
- Goethe University, Department of Pulmonology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age >12 and <45 years
- informed consent
- Known allergy on grass-pollen
Exclusion Criteria:
- age <12 and >45 years
- Clinical asthma requiring regular inhalation
- vital capacity >80%
- FEV1 < 75%
- Chronic disease
- pregnancy
- Inhalative or systemic steroid use
- substance abuse
- incapability of understanding the study's purpose and performance
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
correlation of the blood fatty-acid level and bronchial hyperreactivity, measured as the exhaled NO.
Time Frame: aug 2006 - feb 2007
|
aug 2006 - feb 2007
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stefan Zielen, M.D., Ph.D., Goethe University, Department of Pulmonology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dyerberg J, Bang HO. Lipid metabolism, atherogenesis, and haemostasis in Eskimos: the role of the prostaglandin-3 family. Haemostasis. 1979;8(3-5):227-33. doi: 10.1159/000214314.
- Kitz R, Rose MA, Schubert R, Beermann C, Kaufmann A, Bohles HJ, Schulze J, Zielen S. Omega-3 polyunsaturated fatty acids and bronchial inflammation in grass pollen allergy after allergen challenge. Respir Med. 2010 Dec;104(12):1793-8. doi: 10.1016/j.rmed.2010.06.019. Epub 2010 Jul 15.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2006
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
August 22, 2007
First Submitted That Met QC Criteria
August 22, 2007
First Posted (Estimate)
August 23, 2007
Study Record Updates
Last Update Posted (Estimate)
February 4, 2009
Last Update Submitted That Met QC Criteria
February 3, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 214/06/FFM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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