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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 24, 2014