Back to resultsLipid Formulation to Increase the Bioavailability of Fatty Acids in Cystic Fibrosis (CF) Patients
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
modified lipid formulation
Fish oil
Sponsored by
About this trial
This is an interventional supportive care trial for Cystic Fibrosis
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
- 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
Sites / Locations
- Centre Hospitalier Universitaire Vaudois
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Active
Control
Arm Description
modified lipid formulation
fish oil
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02646995
First Posted
December 22, 2015
Last Updated
June 4, 2018
Sponsor
Société des Produits Nestlé (SPN)
1. Study Identification
Unique Protocol Identification Number
NCT02646995
Brief Title
Lipid Formulation to Increase the Bioavailability of Fatty Acids in Cystic Fibrosis (CF) Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 27, 2017 (Actual)
Study Completion Date
May 4, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
modified lipid formulation
Arm Title
Control
Arm Type
Active Comparator
Arm Description
fish oil
Intervention Type
Dietary Supplement
Intervention Name(s)
modified lipid formulation
Intervention Description
Tested oils will be used in liquid form and encapsulated in soft gelatin capsules.
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish oil
Intervention Description
Fish oil will be used in liquid form and encapsulated in soft gelatin capsules.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
From Baseline till 12 weeks of treatment (V3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Lipid Formulation to Increase the Bioavailability of Fatty Acids in Cystic Fibrosis (CF) Patients
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