Cystic FibrosisPhase 3NCT00959010
Omega 3 Supplementation in Cystic Fibrosis Patients
A Phase 3 study testing omega-3 triglycerides in people with Cystic Fibrosis, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 60 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- omega-3 triglycerides
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2008to Jun 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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%).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis
- Being tested
- omega-3 triglycerides, Placebo
- Keywords
- Omega 3, Cystic Fibrosis, Inflammatory markers
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
omega-3 triglyceridesDietary supplement
capsules containing 300mg of omega-3 triglycerides with 100mg DHA and 150mg EPA, 60mg/kg/day 3 times a day during 12 months.
PlaceboDietary supplement
capsules containing middle chain triglycerides
| Study group | Role | What they receive |
|---|---|---|
| Omega 3 Premium | Experimental | capsules containing 300mg of omega-3 triglycerides with 100mg DHA and 150mg EPA Receives: Dietary Supplement: omega-3 triglycerides |
| Placebo | Placebo comparator | capsules containing middle chain triglycerides Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LTB4/LTB5 ratio from baseline to the end of treatment assessment.
Measured: Assessment at 3-6-12 months
Secondary outcomes (6)
To explore the change in other inflammatory biomarkers such as TNF-alpha, IL-6, IL-8, IL-17 & alpha-1 anti-trypsin.
Measured: Assessments at 3-6 and 12 months
To evaluate the incorporation into cell membrane phospholipids.
Measured: Assessments at 3-6-12 months
To evaluate the effects on the pulmonary function (FEV1) and on the exercise tolerance (VO2 max).
Measured: Assessment at 12 months
To evaluate the effects on the clinical status and the nutritional status.
Measured: Assessments at 3-6-9 and 12 months
To investigate the properties of transepithelial ion transport (sweat test).
Measured: Assessments at 12 months
To evaluate the long term overall safety and tolerability of Omega-3 EFA supplementation in CF patients.
Measured: Assessment at 3-6-9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startOct 2008
- Primary completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence Hanssens, MD, Principal investigator, Queen Fabiola Children's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00959010
- Sponsor's protocol ID
- HU01/PNE/MUCO1
- Other IDs
- 2006-004155-38
- Status last verified
- Oct 2015
- First submitted
- 13 Aug 2009
- Last updated
- 21 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biochemical Effects of a Long-term Supplementation With Omega-3 Polyunsaturated Fatty Acids in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT00959010
- Acronym / sponsor ID
- HU01/PNE/MUCO1
- Conditions
- Cystic Fibrosis
- Keywords
- Omega 3, Cystic Fibrosis, Inflammatory markers
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jun 2011 (actual)
- First posted
- 14 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omega 3 Premium | Experimental | Dietary Supplement: omega-3 triglyceridescapsules containing 300mg of omega-3 triglycerides with 100mg DHA and 150mg EPA |
| Placebo | Placebo comparator | Dietary Supplement: Placebocapsules containing middle chain triglycerides |
Who may qualify
- Ages
- 6 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| omega-3 triglyceridescapsules containing 300mg of omega-3 triglycerides with 100mg DHA and 150mg EPA, 60mg/kg/day 3 times a day during 12 months. | Dietary supplement | Omega 3 Premium |
| Placebocapsules containing middle chain triglycerides | Dietary supplement | Placebo |
Primary outcome
LTB4/LTB5 ratio from baseline to the end of treatment assessment.
Time frame: Assessment at 3-6-12 months
6 secondary outcomes
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
To evaluate the incorporation into cell membrane phospholipids.
Time frame: 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
To evaluate the effects on the clinical status and the nutritional status.
Time frame: Assessments at 3-6-9 and 12 months
To investigate the properties of transepithelial ion transport (sweat test).
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Hanssens, MD principal investigator
Queen Fabiola Children's University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing omega-3 triglycerides in people with Cystic Fibrosis, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LTB4/LTB5 ratio from baseline to the end of treatment assessment. (time frame: Assessment at 3-6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.