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

NCT ID: NCT02646995

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-05-04

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Active

modified lipid formulation

Group Type: EXPERIMENTAL

modified lipid formulation

Intervention Type: DIETARY_SUPPLEMENT

Tested oils will be used in liquid form and encapsulated in soft gelatin capsules.

Control

fish oil

Group Type: ACTIVE_COMPARATOR

Fish oil

Intervention Type: DIETARY_SUPPLEMENT

Fish oil will be used in liquid form and encapsulated in soft gelatin capsules.

Interventions

modified lipid formulation

Tested oils will be used in liquid form and encapsulated in soft gelatin capsules.

Intervention Type: DIETARY_SUPPLEMENT

Fish oil

Fish oil will be used in liquid form and encapsulated in soft gelatin capsules.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

14.18.CLI

Identifier Type: -

Identifier Source: org_study_id