Omega 3 Supplementation in Cystic Fibrosis Patients

October 20, 2015 updated by: Queen Fabiola Children's University Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • Hôpital Universitaire Des Enfants Reine Fabiola

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
LTB4/LTB5 ratio from baseline to the end of treatment assessment.
Time Frame: Assessment at 3-6-12 months
Assessment at 3-6-12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
Assessments at 3-6 and 12 months
To evaluate the incorporation into cell membrane phospholipids.
Time Frame: Assessments at 3-6-12 months
Assessments at 3-6-12 months
To evaluate the effects on the pulmonary function (FEV1) and on the exercise tolerance (VO2 max).
Time Frame: Assessment at 12 months
Assessment at 12 months
To evaluate the effects on the clinical status and the nutritional status.
Time Frame: Assessments at 3-6-9 and 12 months
Assessments at 3-6-9 and 12 months
To investigate the properties of transepithelial ion transport (sweat test).
Time Frame: Assessments at 12 months
Assessments at 12 months
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
Assessment at 3-6-9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Queen Fabiola Children's University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurence Hanssens, MD, Queen Fabiola Children's University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 14, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 20, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HU01/PNE/MUCO1
  • 2006-004155-38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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