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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Giving DHA-rich supplement
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Delta F 508 homozygote Stable clinical situation Exclusion Criteria: -

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

DHA-rich supplement

Placebo

Arm Description

Outcomes

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

Full Information

First Posted
September 12, 2005
Last Updated
September 27, 2011
Sponsor
University Hospital, Ghent
Collaborators
Belgian Society against Cystic Fibrosis
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1. Study Identification

Unique Protocol Identification Number
NCT00221546
Brief Title
Influence of DHA-rich Supplement on DHA-status and Health Evolution of Patients With Cystic Fibrosis
Official Title
Influence of DHA-rich Supplement on DHA-status and Health Evolution of Patients With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Belgian Society against Cystic Fibrosis

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DHA-rich supplement
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Giving DHA-rich supplement
Intervention Description
Giving DHA-rich supplement to patients.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Evolution of the fatty acid profile
Time Frame
during the 2 years of the study
Title
Oxidative stress status
Time Frame
during the 2 years of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Delta F 508 homozygote Stable clinical situation Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Armand Christophe, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
Website University Hospital Ghent

Learn more about this trial

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

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