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Effect of Omega-3 PUFA Supplementation in NAFLD Patients

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Notable

    Phase: Phase 2 to Not applicable

    Interventions: Omega-3 fatty acid diet supplementation (Dietary Supplement), safflower oil (Dietary Supplement) to Fish oil (Dietary Supplement), Safflower oil (Dietary Supplement)

    Study Identification, Study Status, Sponsor/Collaborators, Study Design, Arms and Interventionsv11

  2. Minor

    Trial status: Active, Not Recruiting to Completed

    Study Statusv10

  3. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Status, Contacts/Locationsv9

  4. Notable

    Primary and study completion dates: Feb 2009 to Jun 2010

    Study Statusv8

  5. Minor

    Study Status

    Re-verified, no change to tracked fields

    v7

Show 5 earlier versions

  1. Minor

    Completion date: Oct 2008 to Feb 2009

    Study Statusv6

  2. Notable

    Trial status: Active, Not Recruiting to Recruiting

    Primary completion date: Feb 2009; Completion date: Oct 2006 to Oct 2008; Interventions: Omega-3 fatty acid diet supplementation (Drug) to Omega-3 fatty acid diet supplementation (Dietary Supplement), safflower oil (Dietary Supplement); and 3 more

    Show all 7 changes in this update
    • Notable Trial status: Active, Not Recruiting to Recruiting
    • Minor Primary completion date: Feb 2009
    • Minor Completion date: Oct 2006 to Oct 2008
    • Minor Interventions: Omega-3 fatty acid diet supplementation (Drug) to Omega-3 fatty acid diet supplementation (Dietary Supplement), safflower oil (Dietary Supplement)
    • Minor Secondary endpoints: details revised at 2 of 2 entries
    • Minor Site details revised
    • Minor Study arms: 0 to 2

    Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locationsv5

  3. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Identification, Study Status, Contacts/Locationsv4

  4. Notable

    Primary endpoint revised

    Secondary endpoints: 4 to 2

    Show what changed: Primary endpoints
    • Reduction of intrahepatic fat content as determined by magnetic resonance spectroscopy
    Show what changed: Secondary endpoints
    • Change in serum aminotransferase levels • Change in lipid profile • Change in levels of proinflammatory cytokines • Change in insulin resistance determined by HOMA

    Study Status, Outcome Measuresv3

  5. Minor

    Study Status

    Re-verified, no change to tracked fields

    v2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to determine whether dietary supplementation with omega-3 polyunsaturated fatty acids will decrease the amount of fat in liver.
Trial Details
NCT Number NCT00230113
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Non-Alcoholic Fatty Liver Disease
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov