NCT02646995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2017

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

1.2 years

First QC Date

December 22, 2015

Last Update Submit

June 4, 2018

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Active

EXPERIMENTAL

modified lipid formulation

Dietary Supplement: modified lipid formulation

Control

ACTIVE COMPARATOR

fish oil

Dietary Supplement: Fish oil

Interventions

modified lipid formulationDIETARY_SUPPLEMENT

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

Active
Fish oilDIETARY_SUPPLEMENT

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

Control

Eligibility Criteria

Age5 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Fish Oils

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

OilsLipids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2015

First Posted

January 6, 2016

Study Start

January 1, 2016

Primary Completion

March 27, 2017

Study Completion

May 4, 2017

Last Updated

June 6, 2018

Record last verified: 2018-06

Locations

CH(1)