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

Société des Produits Nestlé (SPN)1 site in 1 country16 target enrollmentJanuary 2016

ConditionsCystic Fibrosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cystic Fibrosis
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 16
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

May 4, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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