NCT01329172

Brief Summary

Background : Cystic fibrosis (CF) patients are prone to recurrent pulmonary infection have different secreted mucin pattern from healthy subjects. Long chain polyunsaturated fatty acids have been shown to influence survival and MUC5B expression in mice model of chronic pulmonary infection. Method : To study the impact of LCPUFA n-3 on MUC5B expression (mRNA level by RT-PCR) collected in airway epithelial cells obtained by nasal brushing. The secondary aim is to assess : MUC1, MUC2, MUC4, MUC5AC, MUC7 expression (mRNA level) in airway epithelial cells obtained by nasal brushing; Lund-Kennedy score; TNK-alpha, IL-6, IL-8 in blood plasma. This study is a double parallel, controlled double blind, randomized clinical trial : LCPUFA n-3 (1 g/day) vs placebo for 6 weeks. 30 subjects will be included in this study. Primary and secondary study end point will be assessed two times: before randomization and after 60 days of treatment. Statistical analysis : Treatment group and placebo will be compared using U-Mann-Whitney, intention to treat and per protocol.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
terminated

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

May 21, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

September 20, 2010

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 5, 2011

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 22, 2017

Status Verified

December 1, 2017

Enrollment Period

7 years

First QC Date

May 21, 2010

Last Update Submit

December 21, 2017

Conditions

Cystic FibrosisDietary Modification

Keywords

PUFACystic FibrosisNasal brushingMucinsMucin production

Outcome Measures

Primary Outcomes (1)

  • Expression of Mucin "MUC5B" by measurement of messenger Ribo Nucleic Acid (mRNA) level in native airway epithelial cells obtained by nasal brushing

    baseline and 2 months

Secondary Outcomes (1)

  • Mucin MUC1, MUC2, MUC4, MUC5AC, MUC7 (mRNA level) in native airway epithelial cells obtained by nasal brushing. Lund-Kennedy score TNF-alpha, IL-6, IL-8 in plasma

    baseline and two months

Study Arms (2)

polyunsaturated fatty acids n-3

EXPERIMENTAL

polyunsaturated fatty acids n-3 (PUFA n-3)

Other: polyunsaturated fatty acids n-3

placebo

PLACEBO COMPARATOR

sun flower oil

Other: placebo

Interventions

polyunsaturated fatty acids n-3OTHER

polyunsaturated fatty acids n-3 1 gram per day during two months

Also known as: PUFA n-3
polyunsaturated fatty acids n-3
placeboOTHER

sun flower oil with Poly Unsaturated Fatty Acid 1g/day

Also known as: PUFA
placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Cystic fibrosis patient
  • Aged 18 to 30 year
  • No modification of long term therapy (Corticoids, antibiotics, pancreatic extract, antiacid) before 4 weeks before randomization

You may not qualify if:

  • Awaiting transplantation
  • Patients on anticoagulants
  • Contraindication to supplementation with polyunsaturated fatty acids
  • Taking antibiotics in progress ( less than 15 days)
  • Taking anti- inflammatory ongoing (more than one week per month , steroids , or nonsteroidal )

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dunkerque Hospital

Dunkirk, France

Location

Lens Hospital

Lens, 62300, France

Location

Clinical Investigation center

Lille, 59037, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Fatty Acids, Omega-3Docosahexaenoic Acids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOils

Study Officials

  • Frédéric GOTTRAND, MD, PhD

    CHRU de Lille et Université Lille 2

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2010

First Posted

April 5, 2011

Study Start

September 20, 2010

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

December 22, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)