Omega 3 Supplementation in Cystic Fibrosis Patients
Avainsanat
Abstrakti
Päivämäärät
| Viimeksi vahvistettu: | 09/30/2015 |
| Ensimmäinen lähetys: | 08/12/2009 |
| Arvioitu ilmoittautuminen lähetetty: | 08/12/2009 |
| Ensimmäinen lähetetty: | 08/13/2009 |
| Viimeisin päivitys lähetetty: | 10/19/2015 |
| Viimeisin päivitys lähetetty: | 10/20/2015 |
| Todellinen opintojen alkamispäivä: | 09/30/2008 |
| Arvioitu ensisijainen valmistumispäivä: | 05/31/2011 |
Ehto tai tauti
Interventio / hoito
Dietary Supplement: Omega 3 Premium
Dietary Supplement: Placebo
Vaihe
Varren ryhmät
| Varsi | Interventio / hoito |
|---|---|
| Experimental: Omega 3 Premium capsules containing 300mg of omega-3 triglycerides with 100mg DHA and 150mg EPA | Dietary Supplement: Omega 3 Premium capsules containing 300mg of omega-3 triglycerides with 100mg DHA and 150mg EPA, 60mg/kg/day 3 times a day during 12 months. |
| Placebo Comparator: Placebo capsules containing middle chain triglycerides | Dietary Supplement: Placebo capsules containing middle chain triglycerides |
Kelpoisuusehdot
| Tutkimukseen soveltuvat iät | 6 Years Vastaanottaja 6 Years |
| Sukupuolet, jotka ovat kelpoisia tutkimukseen | All |
| Hyväksyy terveelliset vapaaehtoiset | Joo |
| Kriteeri | Inclusion Criteria: 1. Male or female patient over 6 years of age at visit 1 with stable cystic fibrosis 2. Documented Homozygous for DeltaF508 mutation 3. Patient treated with stable dose of Azithromycine since at least 3 months 4. Able to perform pulmonary function test and swallow capsules 5. Female patient of childbearing potential must have a negative serum pregnancy test prior to enrolment and must agree to practice effective birth control during the study and 6 weeks thereafter 6. Signed informed consent obtained from the patient, or in case the patient is minor,from patient's legally acceptable representative (parents or guardians) according to ICH & local regulations. Child assent will be nevertheless obtained Exclusion Criteria: 1. Ongoing acute illness including acute upper or lower respiratory infections within 2 weeks before baseline evaluation. 2. Abnormalities on screening chest x-ray (or CT-scan) suggesting clinically active pulmonary disease other than CF, or new, significant abnormalities such as atelectasis or pleural effusion which may be indicative of clinically active pulmonary involvement secondary to CF. 3. Any chronic (> 1 week daily) oral or intravenous inflammatory treatment, other than Azithromycine, given to the patient within 3 months before start of study treatment. 4. Active bleeding or increased risk of bleeding (rate of platelets < 50,000/mm3,patient treatment by anticoagulant or antiplatelet agents, disturbances of haemostasis with PTT <70%, bleeding disorders). 5. Patient has significant liver disease, defined as having elevated liver function tests with values 2-fold higher than the upper normal range of the investigational local lab or having abnormal ultrasound such as signs of cirrhosis. 6. Hypercholesterolemia (>240mg%). 7. Patient is pregnant or a breast-feeding mother 8. Patient is participating or has participated in another investigational drug trial or is receiving or has received an investigational drug within the last 28 days before entry into this study. 9. Patient is unlikely to comply with the visits scheduled in the protocol or enable to follow the study procedure. |
Tulokset
Ensisijaiset tulosmittaukset
1. LTB4/LTB5 ratio from baseline to the end of treatment assessment. [Assessment at 3-6-12 months]
Toissijaiset tulosmittaukset
1. To explore the change in other inflammatory biomarkers such as TNF-alpha, IL-6, IL-8, IL-17 & alpha-1 anti-trypsin. [Assessments at 3-6 and 12 months]
2. To evaluate the incorporation into cell membrane phospholipids. [Assessments at 3-6-12 months]
3. To evaluate the effects on the pulmonary function (FEV1) and on the exercise tolerance (VO2 max). [Assessment at 12 months]
4. To evaluate the effects on the clinical status and the nutritional status. [Assessments at 3-6-9 and 12 months]
5. To investigate the properties of transepithelial ion transport (sweat test). [Assessments at 12 months]
6. To evaluate the long term overall safety and tolerability of Omega-3 EFA supplementation in CF patients. [Assessment at 3-6-9 and 12 months]
