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Influence of DHA-Rich Supplement on DHA-Status and Health Evolution of Patients With Cystic Fibrosis
This study is ongoing, but not recruiting participants.
First Received: September 12, 2005   Last Updated: December 19, 2007   History of Changes
Sponsors and Collaborators: University Hospital, Ghent
Belgian Society against Cystic Fibrosis
Information provided by: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00221546
  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 versus placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
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

Secondary Outcome Measures:
  • Evolution of the fatty acid profile
  • Oxidative stress status

Estimated Enrollment: 30
Study Start Date: September 2004
Estimated Study Completion Date: April 2007
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:
No publications provided

Study ID Numbers: 2001/220
Study First Received: September 12, 2005
Last Updated: December 19, 2007
ClinicalTrials.gov Identifier: NCT00221546     History of Changes
Health Authority: Belgium: Institutional Review Board

Study placed in the following topic categories:
Digestive System Diseases
Genetic Diseases, Inborn
Respiratory Tract Diseases
Cystic Fibrosis
Fibrosis
Lung Diseases
Infant, Newborn, Diseases
Pancreatic Diseases

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

ClinicalTrials.gov processed this record on September 11, 2009