Status:
COMPLETED
Omega 3 Supplementation in Cystic Fibrosis Patients
Lead Sponsor:
Queen Fabiola Children's University Hospital
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-60 years
Phase:
PHASE3
Brief Summary
Essential fatty acids (EFA) deficiency has been often reported in patients with cystic fibrosis (CF), particularly in those homozygous for the DF508 mutation. Clinical symptoms of CF may be influenced...
Eligibility Criteria
Inclusion
- Male or female patient over 6 years of age at visit 1 with stable cystic fibrosis
- Documented Homozygous for DeltaF508 mutation
- Patient treated with stable dose of Azithromycine since at least 3 months
- Able to perform pulmonary function test and swallow capsules
- 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
- 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
- Ongoing acute illness including acute upper or lower respiratory infections within 2 weeks before baseline evaluation.
- 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.
- 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.
- 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).
- 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.
- Hypercholesterolemia (\>240mg%).
- Patient is pregnant or a breast-feeding mother
- 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.
- Patient is unlikely to comply with the visits scheduled in the protocol or enable to follow the study procedure.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00959010
Start Date
October 1 2008
Last Update
October 21 2015
Active Locations (1)
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1
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, Belgium, 1020