Cystic Fibrosis
Conditions
Brief summary
The purpose of this trial is to evaluate if the use of a newly developed lipid formulation versus fish oil would better enable the absorption of essential fatty acids after 12 weeks of supplementation.
Interventions
DIETARY_SUPPLEMENTmodified lipid formulation
Tested oils will be used in liquid form and encapsulated in soft gelatin capsules.
DIETARY_SUPPLEMENTFish oil
Fish oil will be used in liquid form and encapsulated in soft gelatin capsules.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Previously diagnosed CF according to established criteria (diagnosis of CF will be based on either two positive sweat chloride tests of \>60 mEq/L or the identification of two detectable mutations associated with CF) 2. Exocrine pancreatic insufficiency defined by pathological fecal elastase (\<15µg/g) found in the Medical History of the patient 3. Informed consent letter signed and dated by their parents or legal guardians before inclusion in the study, and assent signed and dated by the child if he or she is ≥ 14 years old
Exclusion criteria
1. Any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for CF or for CF-related conditions within 4 weeks prior to baseline 2. Exposure to another investigational drug or dietary supplements and enteral nutrition containing EPA and docosahexaenoic acid (DHA), Fish or the use of any other supplement containing fish oil within 4 weeks prior to baseline. 3. Treatment with intravenous antibiotics within 4 weeks prior to baseline 4. Newly started oral antibiotic treatment within 4 weeks prior to Baseline 5. History of solid organ or hematological transplantation 6. Ongoing immunosuppressive therapy (other than corticosteroids) within 3 weeks prior to baseline 7. Major complications of lung disease (including massive hemoptysis, pneumothorax, or pleural effusion) within 8 weeks prior to baseline 8. Evidence of pulmonary exacerbation or acute upper or lower respiratory tract infection (including viral illnesses) within 3 weeks prior to baseline 9. Having donated blood or had a transfusion of blood/blood products during the trial and 3 months prior to screening or expected to do so during the study 10. Any bleeding disorders at screening 11. Patient who cannot be expected to comply with the study procedures. 12. Currently participating or having participated in another clinical trial within 8 weeks prior to baseline. 13. Any known food allergy 14. Incapacity to swallow capsules
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of accretion in erythrocytes of eicosapentanoic acid (EPA) between the 2 groups from Baseline to V3 (12 weeks of treatment), as determined by gas chromatography | From Baseline till 12 weeks of treatment (V3) | determine the accretion in erythrocytes of EPA derived from the modified lipd formulation as compared to EPA from fish oil between the 2 groups after 12 weeks of supplementation |
Countries
Switzerland
Outcome results
None listed