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Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis

Primary Purpose

End Stage Renal Disease

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
omega-3
empty soft gelatin capsules
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring omega-3 fatty acids, hemodialysis, oxidative stress, dyslipidemia

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients between 8 and 18 years old
  • Patients treated with HD for at least 6 months

Exclusion Criteria:

  • Patients with malignancy and active inflammatory disease.
  • Patients who received vitamin E or any antioxidant treatment during the past 3 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    omega-3 group

    placebo group

    Arm Description

    omega-3 soft gelatin capsules 1000 mg (500mg EPA+250mg DHA)once daily for four months

    empty soft gelatin capsules with matched size, color and shape once daily for four months

    Outcomes

    Primary Outcome Measures

    effect on oxidative stress status via measurement of superoxide dismutase and glutathione peroxidase and malondialdehyde

    Secondary Outcome Measures

    effect on serum lipid levels (HDL cholesterol, LDL cholesterol, total cholesterol, and triglycerides)

    Full Information

    First Posted
    October 11, 2015
    Last Updated
    October 20, 2015
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02581449
    Brief Title
    Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis
    Official Title
    Evaluation of the Effect of Omega-3 Fatty Acids Supplementation on Pediatric Patients Undergoing Hemodialysis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2015 (undefined)
    Primary Completion Date
    January 2016 (Anticipated)
    Study Completion Date
    January 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of the study is to evaluate the effect of omega-3 fatty acids supplementation on pediatric patients undergoing hemodialysis via the measurement of the following before and after omega-3 administration:oxidative stress markers, inflammatory markers and serum lipids.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    End Stage Renal Disease
    Keywords
    omega-3 fatty acids, hemodialysis, oxidative stress, dyslipidemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    omega-3 group
    Arm Type
    Experimental
    Arm Description
    omega-3 soft gelatin capsules 1000 mg (500mg EPA+250mg DHA)once daily for four months
    Arm Title
    placebo group
    Arm Type
    Placebo Comparator
    Arm Description
    empty soft gelatin capsules with matched size, color and shape once daily for four months
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    omega-3
    Other Intervention Name(s)
    NOW foods omega-3 softgels
    Intervention Description
    dietary supplement
    Intervention Type
    Other
    Intervention Name(s)
    empty soft gelatin capsules
    Intervention Description
    empty softgels of matched size, shape and color
    Primary Outcome Measure Information:
    Title
    effect on oxidative stress status via measurement of superoxide dismutase and glutathione peroxidase and malondialdehyde
    Time Frame
    four months
    Secondary Outcome Measure Information:
    Title
    effect on serum lipid levels (HDL cholesterol, LDL cholesterol, total cholesterol, and triglycerides)
    Time Frame
    four months
    Other Pre-specified Outcome Measures:
    Title
    effect on inflammation via measurement of C- Reactive Protein
    Time Frame
    four months
    Title
    effect on nitric oxide (serum concentration)
    Time Frame
    four months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients between 8 and 18 years old Patients treated with HD for at least 6 months Exclusion Criteria: Patients with malignancy and active inflammatory disease. Patients who received vitamin E or any antioxidant treatment during the past 3 months.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ain Shams
    Organizational Affiliation
    university
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Effect of Omega-3 Fatty Acids on Oxidative Stress and Dyslipidemia in Pediatric Patients Undergoing Hemodialysis

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