Lipid Formulation to Increase the Bioavailability of Fatty Acids in Cystic Fibrosis (CF) Patients

Study Overview
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Brief Summary
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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.

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Dietary Supplement: modified lipid formulation
* Dietary Supplement: Fish oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exocrine pancreatic insufficiency defined by pathological fecal elastase (<15µg/g) found in the Medical History of the patient 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: 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 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. Treatment with intravenous antibiotics within 4 weeks prior to baseline Newly started oral antibiotic treatment within 4 weeks prior to Baseline History of solid organ or hematological transplantation Ongoing immunosuppressive therapy (other than corticosteroids) within 3 weeks prior to baseline Major complications of lung disease (including massive hemoptysis, pneumothorax, or pleural effusion) within 8 weeks prior to baseline Evidence of pulmonary exacerbation or acute upper or lower respiratory tract infection (including viral illnesses) within 3 weeks prior to baseline 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 Any bleeding disorders at screening Patient who cannot be expected to comply with the study procedures. Currently participating or having participated in another clinical trial within 8 weeks prior to baseline. Any known food allergy Incapacity to swallow capsules

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>modified lipid formulation | Dietary Supplement: modified lipid formulation<br>* Tested oils will be used in liquid form and encapsulated in soft gelatin capsules.<br>|
| Active Comparator: Control<br>fish oil | Dietary Supplement: Fish oil<br>* Fish oil will be used in liquid form and encapsulated in soft gelatin capsules.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | From Baseline till 12 weeks of treatment (V3) |