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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Docosahexaenoic acid
Sunflower Oil
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

6 Years - 30 Years (Child, Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Docosahexaenoic acid

    Sunflower oil

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    Change in 8-isoprostane level in urine.
    Measured by urinalysis (Immunoassay).

    Secondary Outcome Measures

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

    Full Information

    First Posted
    February 16, 2016
    Last Updated
    May 23, 2019
    Sponsor
    Hospices Civils de Lyon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02690857
    Brief Title
    Study of Docosahexanoic Acid in Patients With Cystic Fibrosis (CF)
    Acronym
    OMEGAMUCO
    Official Title
    Efficacy of Docosahexanoic Acid on Lipid Peroxidation in Subjects With Cystic Fibrosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2010 (undefined)
    Primary Completion Date
    May 2010 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospices Civils de Lyon

    4. Oversight

    5. Study Description

    Brief Summary
    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.

    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
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Docosahexaenoic acid
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    Sunflower oil
    Arm Type
    Placebo Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Docosahexaenoic acid
    Intervention Type
    Drug
    Intervention Name(s)
    Sunflower Oil
    Primary Outcome Measure Information:
    Title
    Change in 8-isoprostane level in urine.
    Description
    Measured by urinalysis (Immunoassay).
    Time Frame
    Day 14
    Secondary Outcome Measure Information:
    Title
    Change in 11-dehydro-thromboxane B2 in urine.
    Description
    Measured by urinalysis (Immunoassay).
    Time Frame
    Day 28
    Title
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
    Description
    Measured by vital signs
    Time Frame
    Day 28
    Title
    Change in percent predicted forced expiratory volume in 1 second
    Description
    Spirometry
    Time Frame
    from baseline through Day 28
    Title
    Evaluation of the effect of DHA on specific biomarkers.
    Description
    Gas chromatography, immunoassays, fluorimetry. (in plasma : lipids, vitamin E and in platelet : lipids, vitamin E, thromboxane B2, malondialdehyde).
    Time Frame
    Day 28

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27914512
    Citation
    Vericel E, Mazur S, Colas R, Delaup V, Calzada C, Reix P, Durieu I, Lagarde M, Bellon G. Moderate intake of docosahexaenoic acid raises plasma and platelet vitamin E levels in cystic fibrosis patients. Prostaglandins Leukot Essent Fatty Acids. 2016 Dec;115:41-47. doi: 10.1016/j.plefa.2016.10.008. Epub 2016 Oct 18.
    Results Reference
    result

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

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