NCT00221546CompletedPhase 2
Influence of DHA-rich Supplement on DHA-status and Health Evolution of Patients With Cystic Fibrosis
University Hospital, Ghent1 site in 1 country17 target enrollmentStarted: September 2007Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University Hospital, Ghent
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Clinical evolution: weight, height, pulmonary function and infection frequency before the study start and during the 2 years of the study
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Delta F 508 homozygote
- •Stable clinical situation
Exclusion Criteria
- Not provided
Arms & Interventions
DHA-rich supplement
Active Comparator
Intervention: Giving DHA-rich supplement (Drug)
Placebo
Placebo Comparator
Intervention: Giving DHA-rich supplement (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- Oxidative stress status(during the 2 years of the study)
- Evolution of the fatty acid profile(during the 2 years of the study)
Investigators
Study Sites (1)
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