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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02048592 |
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Date of registration:
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16/12/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impact of Immunonutrition on the Patients With Cystic Fibrosis
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Scientific title:
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Impact of Immunonutrition on the Patients With Cystic Fibrosis |
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Date of first enrolment:
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September 2013 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02048592 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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Phase:
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Phase 4
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Countries of recruitment
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Czech Republic
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Contacts
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Name:
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Jiri Charvat, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty hospital Motol |
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Name:
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Libor Fila, MD |
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Address:
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Telephone:
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+420224436630 |
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Email:
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libor.fila@fnmotol.cz |
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Affiliation:
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Name:
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Ondrej Hloch, MD |
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Address:
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Telephone:
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+420224434098 |
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Email:
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o.hloch@gmail.com |
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Affiliation:
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Name:
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Milan Kvapil, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty hospital Motol |
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Name:
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Ondrej Hloch, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Faculty hospital Motol |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Cystic fibrosis
- adult, elder 18 years
- enteral nutrition at least for the last 12 monthes
Exclusion Criteria:
- patient waiting for lung transplant
- patients with another life limiting disease-e.g. cancers
Age minimum:
18 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Oxidative Stress
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Cystic Fibrosis
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Malnutrition
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Intervention(s)
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Dietary Supplement: Impact-Nutridrink
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Dietary Supplement: Nutridrink-Impact
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Primary Outcome(s)
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to evaluate the change of oxidative stress in patients with cystic fibrosis induced by immunonutrition
[Time Frame: 16 weeks]
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Secondary Outcome(s)
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to evaluate the change of inflammatory parameters in patients with cystic fibrosis induced by the application of immunonutrition
[Time Frame: 16 weeks]
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Secondary ID(s)
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FN Motol-project 6008
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EK-942/13
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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