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

Cystic Fibrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02646995
• Other study ID #: 14.18.CLI
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: May 4, 2017

Study information

• Verified date: June 2018
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 4, 2017
• Est. primary completion date: March 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Dietary Supplement:
• modified lipid formulation
Tested oils will be used in liquid form and encapsulated in soft gelatin capsules.
• Fish oil
Fish oil will be used in liquid form and encapsulated in soft gelatin capsules.

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)