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

Phase 2

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: Giving DHA-rich supplement

• Registration Number: NCT00221546
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Study Start: 2007-09
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-27
• Last Update Posted: 2011-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Delta F 508 homozygote
• Stable clinical situation

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DHA-rich supplement	Giving DHA-rich supplement	-
Placebo	Giving DHA-rich supplement	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Oxidative stress status	during the 2 years of the study
Evolution of the fatty acid profile	during the 2 years of the study

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium