Study of Docosahexanoic Acid in Patients With Cystic Fibrosis (CF) (OMEGAMUCO)

May 23, 2019 updated by: Hospices Civils de Lyon

Efficacy of Docosahexanoic Acid on Lipid Peroxidation in Subjects With Cystic Fibrosis

Patients with Cystic Fibrosis have increased oxidative stress and impaired antioxidant systems. Under certain conditions, docosahexaenoic acid (DHA) intake may have a favorable role in reducing redox status.

In this randomized, double-blind, cross-over study, DHA (Pro-Mind) and placebo (sunflower oil) capsules, will be given, daily to 10 patients, 5 mg/kg for 2 weeks then 10 mg/kg for the next 2 weeks. Biomarkers of lipid peroxidation and vitamin E levels will be measured. Plasma and platelet lipid compositions will be determined.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male with confirmed diagnosis of Cystic Fibrosis with a sweat chloride > 60 mmol/L and a pancreatic insufficiency.
  • Subjects will be aged between 6 and 18 years and be prepubescent, or aged between 18 and 30 years
  • Body weight > 26 kg
  • Stable CF disease as judged by the investigator.
  • Subjects must have an Forced Expiratory Volume at one second > 40 % of predicted normal for age, sex and height at the screening visit.
  • Subjects should not have enteral or parenteral nutrition.
  • No periodic IV lipidic emulsion administration. Subjects must not consume food supplements rich in OMEGA-3 on a regular basis.

Exclusion Criteria:

  • Subjects with cirrhosis and portal hypertension.
  • Subjects with Cystic fibrosis related diabetes.
  • Concomitant participation in another clinical study.
  • Known allergy or intolerance to the active principle.
  • Subjects with major blood coagulation anomalies, patients under anticoagulants or aspirin (long term therapy).
  • Subjects on a transplant waiting list.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Docosahexaenoic acid

Each capsule of DHA contains 100 mg DHA in triglycerides from algal oil, 0.125 mg alpha-tocopherol and 0.125 mg ascorbic acid.

Subjects receive an orally and daily ingestion of DHA capsules (5mg/kg for 15 days followed by 10 mg/kg for another 15 days without interruption between the 2 periods).

Placebo Comparator: Sunflower oil
Placebo capsules contain the same quantities of antioxidants and triglycerides of sunflower oil. Subjects receive an orally and daily ingestion of placebo capsules for 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 8-isoprostane level in urine.
Time Frame: Day 14
Measured by urinalysis (Immunoassay).
Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 11-dehydro-thromboxane B2 in urine.
Time Frame: Day 28
Measured by urinalysis (Immunoassay).
Day 28
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Day 28
Measured by vital signs
Day 28
Change in percent predicted forced expiratory volume in 1 second
Time Frame: from baseline through Day 28
Spirometry
from baseline through Day 28
Evaluation of the effect of DHA on specific biomarkers.
Time Frame: Day 28
Gas chromatography, immunoassays, fluorimetry. (in plasma : lipids, vitamin E and in platelet : lipids, vitamin E, thromboxane B2, malondialdehyde).
Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

February 16, 2016

First Submitted That Met QC Criteria

February 23, 2016

First Posted (Estimate)

February 24, 2016

Study Record Updates

Last Update Posted (Actual)

May 28, 2019

Last Update Submitted That Met QC Criteria

May 23, 2019

Last Verified

February 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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