NCT00221546

Brief Summary

Investigation of the influence of giving DHA-rich supplement versus placebo on DHA-status and health evolution of patients with cystic fibrosis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2

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

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.9 years until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

September 28, 2011

Status Verified

September 1, 2011

Enrollment Period

1 year

First QC Date

September 12, 2005

Last Update Submit

September 27, 2011

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Clinical evolution: weight, height, pulmonary function and infection frequency before the study start and during the 2 years of the study

    before the study start and during the 2 years of the study

Secondary Outcomes (2)

  • Evolution of the fatty acid profile

    during the 2 years of the study

  • Oxidative stress status

    during the 2 years of the study

Study Arms (2)

DHA-rich supplement

ACTIVE COMPARATOR
Drug: Giving DHA-rich supplement

Placebo

PLACEBO COMPARATOR
Drug: Giving DHA-rich supplement

Interventions

Giving DHA-rich supplementDRUG

Giving DHA-rich supplement to patients.

DHA-rich supplementPlacebo

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Delta F 508 homozygote
  • Stable clinical situation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

  • Armand Christophe, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

September 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

September 28, 2011

Record last verified: 2011-09

Locations

BE(1)