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Influence of DHA-rich Supplement on DHA-status and Health Evolution of Patients With Cystic Fibrosis

This study has been completed.
Sponsor:
Collaborator:
Belgian Society against Cystic Fibrosis
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00221546
First received: September 12, 2005
Last updated: September 27, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Cystic Fibrosis
 Drug: Giving DHA-rich supplement
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Influence of DHA-rich Supplement on DHA-status and Health Evolution of Patients With Cystic Fibrosis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Clinical evolution: weight, height, pulmonary function and infection frequency before the study start and during the 2 years of the study [ Time Frame: before the study start and during the 2 years of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evolution of the fatty acid profile [ Time Frame: during the 2 years of the study ] [ Designated as safety issue: No ]
  • Oxidative stress status [ Time Frame: during the 2 years of the study ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DHA-rich supplement Drug: Giving DHA-rich supplement
Giving DHA-rich supplement to patients.
Placebo Comparator: Placebo Drug: Giving DHA-rich supplement
Giving DHA-rich supplement to patients.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Delta F 508 homozygote
  • Stable clinical situation

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221546

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Belgian Society against Cystic Fibrosis
Investigators
Principal Investigator: Armand Christophe, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Website University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00221546     History of Changes
Other Study ID Numbers: 2001/220
Study First Received: September 12, 2005
Last Updated: September 27, 2011
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
 Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013