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Omega 3 Supplementation in Cystic Fibrosis Patients

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 3

Locations

Belgium

Study Type

Interventional

Intervention

omega-3 triglycerides

Placebo

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Omega 3, Cystic Fibrosis, Inflammatory markers

Eligibility Criteria

6 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Hôpital Universitaire Des Enfants Reine Fabiola

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Omega 3 Premium

Placebo

Arm Description

capsules containing 300mg of omega-3 triglycerides with 100mg DHA and 150mg EPA

capsules containing middle chain triglycerides

Outcomes

Primary Outcome Measures

LTB4/LTB5 ratio from baseline to the end of treatment assessment.

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.

To evaluate the incorporation into cell membrane phospholipids.

To evaluate the effects on the pulmonary function (FEV1) and on the exercise tolerance (VO2 max).

To evaluate the effects on the clinical status and the nutritional status.

To investigate the properties of transepithelial ion transport (sweat test).

To evaluate the long term overall safety and tolerability of Omega-3 EFA supplementation in CF patients.

Full Information

NCT ID

NCT00959010

First Posted

August 13, 2009

Last Updated

October 20, 2015

Sponsor

Queen Fabiola Children's University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00959010

Brief Title

Omega 3 Supplementation in Cystic Fibrosis Patients

Official Title

Biochemical Effects of a Long-term Supplementation With Omega-3 Polyunsaturated Fatty Acids in Cystic Fibrosis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Queen Fabiola Children's University Hospital

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

Omega 3, Cystic Fibrosis, Inflammatory markers

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Omega 3 Premium

Arm Type

Experimental

Arm Description

capsules containing 300mg of omega-3 triglycerides with 100mg DHA and 150mg EPA

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

capsules containing middle chain triglycerides

Intervention Type

Dietary Supplement

Intervention Name(s)

omega-3 triglycerides

Intervention Description

capsules containing 300mg of omega-3 triglycerides with 100mg DHA and 150mg EPA, 60mg/kg/day 3 times a day during 12 months.

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

capsules containing middle chain triglycerides

Primary Outcome Measure Information:

Title

LTB4/LTB5 ratio from baseline to the end of treatment assessment.

Time Frame

Assessment at 3-6-12 months

Secondary Outcome Measure Information:

Title

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

Title

To evaluate the incorporation into cell membrane phospholipids.

Time Frame

Assessments at 3-6-12 months

Title

To evaluate the effects on the pulmonary function (FEV1) and on the exercise tolerance (VO2 max).

Time Frame

Assessment at 12 months

Title

To evaluate the effects on the clinical status and the nutritional status.

Time Frame

Assessments at 3-6-9 and 12 months

Title

To investigate the properties of transepithelial ion transport (sweat test).

Time Frame

Assessments at 12 months

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Laurence Hanssens, MD

Organizational Affiliation

Queen Fabiola Children's University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital Universitaire Des Enfants Reine Fabiola

City

Brussels

ZIP/Postal Code

1020

Country

Belgium

12. IPD Sharing Statement

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Omega 3 Supplementation in Cystic Fibrosis Patients

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