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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:
ClinicalTrials.gov Identifier:
NCT00221546
First Posted: September 22, 2005
Last Update Posted: September 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Belgian Society against Cystic Fibrosis
Information provided by (Responsible Party):
University Hospital, Ghent
  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
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Evolution of the fatty acid profile [ Time Frame: during the 2 years of the study ]
  • Oxidative stress status [ Time Frame: during the 2 years of the study ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Delta F 508 homozygote
  • Stable clinical situation

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00221546     History of Changes
Other Study ID Numbers: 2001/220
First Submitted: September 12, 2005
First Posted: September 22, 2005
Last Update Posted: September 28, 2011
Last Verified: September 2011

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