Omega 3 Supplementation in Cystic Fibrosis Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Queen Fabiola Children's University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Queen Fabiola Children's University Hospital
ClinicalTrials.gov Identifier:
NCT00959010
First received: August 13, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
  Purpose

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 by correcting EFA deficiency. Nevertheless, the value of EFA supplementation in CF remains controversial. Within this multicentric and international randomized placebo-controlled trial it will be evaluated, according to recommendations of Cochrane analysis, beneficial effects of an oral supplementation with polyunsaturated fatty acids on selected biochemical and functional outcome parameters such as inflammatory biomarkers, incorporation into cell membrane phospholipids, lung function, exercise tolerance, clinical and nutritional status and properties of transepithelial ion transport. The study will be undertaken in a cohort of CF patients aged over 6 years old (60 patients), homozygous for the DF508 mutation and treated by Azithromycine. Supplementation will be performed with a triglyceride source at a daily dose of 60 mg/kg of omega-3 polyunsaturated fatty acids (Omega 3 Premiumâ, Laboratoires Ponroy, France). Before enrolled into the trial and during the study, patients will undergo nutritional assessment by evaluation of total and fat dietary intake and overall calorie intake using a 3-days diet records and a food frequency questionnaire. Plasma and erythrocyte membrane EFA profiles and inflammatory markers will be monitored in baseline conditions, at 3, at 6 and 12 months after starting the treatment. Lung function will be performed at each patient visit and an exercise test will be done before and at the end of the treatment. Properties of ion transport will be searched by sweat testing before and at the end of the treatment.


Condition Intervention Phase
Cystic Fibrosis
Dietary Supplement: omega-3 triglycerides
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biochemical Effects of a Long-term Supplementation With Omega-3 Polyunsaturated Fatty Acids in Cystic Fibrosis

Resource links provided by NLM:


Further study details as provided by Queen Fabiola Children's University Hospital:

Primary Outcome Measures:
  • LTB4/LTB5 ratio from baseline to the end of treatment assessment. [ Time Frame: Assessment at 3-6-12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To explore the change in other inflammatory biomarkers such as TNF-alpha, IL-6, IL-8, IL-17 & alpha-1 anti-trypsin. [ Time Frame: Assessments at 3-6 and 12 months ] [ Designated as safety issue: No ]
  • To evaluate the incorporation into cell membrane phospholipids. [ Time Frame: Assessments at 3-6-12 months ] [ Designated as safety issue: No ]
  • To evaluate the effects on the pulmonary function (FEV1) and on the exercise tolerance (VO2 max). [ Time Frame: Assessment at 12 months ] [ Designated as safety issue: No ]
  • To evaluate the effects on the clinical status and the nutritional status. [ Time Frame: Assessments at 3-6-9 and 12 months ] [ Designated as safety issue: Yes ]
  • To investigate the properties of transepithelial ion transport (sweat test). [ Time Frame: Assessments at 12 months ] [ Designated as safety issue: No ]
  • To evaluate the long term overall safety and tolerability of Omega-3 EFA supplementation in CF patients. [ Time Frame: Assessment at 3-6-9 and 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: October 2008
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omega 3 Premium
capsules containing 300mg of omega-3 triglycerides with 100mg DHA and 150mg EPA
Dietary Supplement: omega-3 triglycerides
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

  Eligibility

Ages Eligible for Study:   6 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00959010

Contacts
Contact: Laurence Hanssens, MD +32/2/477.23.41 laurence.hanssens@huderf.be
Contact: Bernard Wenderickx +32/2/477.32.88 bernard.wenderickx@huderf.be

Locations
Belgium
Hôpital Universitaire Des Enfants Reine Fabiola Recruiting
Brussels, Belgium, 1020
Contact: Daniel Cloquet    +32/2/477.32.70    daniel.cloquet@huderf.be   
Contact: Bernard Wenderickx    +32/2/477.32.88    bernard.wenderickx@huderf.be   
Principal Investigator: Laurence Hanssens, MD         
Sponsors and Collaborators
Queen Fabiola Children's University Hospital
Investigators
Principal Investigator: Laurence Hanssens, MD Queen Fabiola Children's University Hospital
  More Information

No publications provided

Responsible Party: Thierry Schurmans, Hôpital Universitaire Des Enfants Reine Fabiola
ClinicalTrials.gov Identifier: NCT00959010     History of Changes
Other Study ID Numbers: HU01/PNE/MUCO1, 2006-004155-38
Study First Received: August 13, 2009
Last Updated: August 13, 2009
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Queen Fabiola Children's University Hospital:
Omega 3
Cystic Fibrosis
Inflammatory markers

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014