<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03280615</url>
  </required_header>
  <id_info>
    <org_study_id>Omegarenal</org_study_id>
    <nct_id>NCT03280615</nct_id>
  </id_info>
  <brief_title>Omega 3 Fatty Acids in Patients With Chronic Renal Disease</brief_title>
  <official_title>Effects of the Supplementation With Omega 3 Fatty Acids in Patients With Chronic Renal Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Servicio de Salud Metropolitano Oriente</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chile</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the tolerance and efficacy of an omega 3 fatty acids supplement on renal and&#xD;
      vascular function and inflammatory parameters in patients with chronic renal disease&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a double blind trial in patients with chronic renal disease, the effects of a 3.7 g&#xD;
      supplement of docosahexanoic and eicosapentanoic acids or a supplement of a similar dose of&#xD;
      corn oil during 12 weeks, will be assessed on the following parameters:&#xD;
&#xD;
        1. Urine albumin excretion&#xD;
&#xD;
        2. Renal function measured with serum creatinine, cystatin C and beta-2 microglobulin&#xD;
&#xD;
        3. Carotid intima media thickness and pulse wave velocity&#xD;
&#xD;
        4. Inflammation status assessed measuring serum levels of C reactive protein and&#xD;
           interleukin 6&#xD;
&#xD;
        5. Metabolic control of diabetes&#xD;
&#xD;
        6. Serum lipid levels&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 20, 2017</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants will be randomly selected to receive 3.7 g of a supplement containing docosahexanoic and eicosapentanoic acids or a supplement containing corn oil. The supplements will be provided for 12 weeks</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>Identical sachets containind the study supplement or corn oil will be number coded and provided to participants</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With a Urine Albumin Excretion Decrease of 20% or More</measure>
    <time_frame>At baseline and 12 weeks of intervention</time_frame>
    <description>Number of participants in whom urine albumin excretion in a spot urine sample at the end of follow up, expressed as mg/g creatinine, decreased by 20% or more</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in C Reactive Protein Levels at 12 Weeks of Intervention</measure>
    <time_frame>At baseline and 12 weeks of intervention</time_frame>
    <description>Blood C reactive protein measured at baseline and the end of the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pulse Wave Velocity at 12 Weeks of Intervention</measure>
    <time_frame>At baseline and 12 weeks of intervention</time_frame>
    <description>Measurement of pulse wave velocity using a oscillometric device measured at baseline and end of follow up and expressed ad m/s</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Renal Insufficiency, Chronic</condition>
  <arm_group>
    <arm_group_label>Omega 3 fatty acids</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Corn oil</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Supplementation of 3.7 g of corn oil per day during 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Omega 3 fatty acids</intervention_name>
    <description>Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids</description>
    <arm_group_label>Omega 3 fatty acids</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Corn oil</intervention_name>
    <description>Corn oil will be the placebo comparator for omega 3 fatty acids supplement</description>
    <arm_group_label>Corn oil</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Urinary albumin excretion over 30 mg/g creatinin&#xD;
&#xD;
          -  Chronic renal failure stage 2 to 4&#xD;
&#xD;
          -  Absence of serious conditions such as cáncer, decompensated heart failure, chronic&#xD;
             infections and severe arterial lesions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blood glucose levels over 180 mg/dl or glycosilated hemoglobin over 8%&#xD;
&#xD;
          -  Presence of cognitive impairment that does not allow to sigin a written informed&#xD;
             consent&#xD;
&#xD;
          -  Alcohol or illicit drug abuse&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Nutrition and Food Technology University of Chile</name>
      <address>
        <city>Santiago</city>
        <state>Metropolitana</state>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <reference>
    <citation>Shapiro H, Theilla M, Attal-Singer J, Singer P. Effects of polyunsaturated fatty acid consumption in diabetic nephropathy. Nat Rev Nephrol. 2011 Feb;7(2):110-21. doi: 10.1038/nrneph.2010.156. Epub 2010 Dec 7.</citation>
    <PMID>21135888</PMID>
  </reference>
  <reference>
    <citation>Borg M, Svensson M, Povlsen JV, Schmidt EB, Aalkjaer C, Christensen JH, Ivarsen P. Long chain n-3 polyunsaturated fatty acids and vascular function in patients with chronic kidney disease and healthy subjects: a cross-sectional and comparative study. BMC Nephrol. 2016 Nov 21;17(1):184. doi: 10.1186/s12882-016-0393-5.</citation>
    <PMID>27871238</PMID>
  </reference>
  <reference>
    <citation>Xu T, Sun Y, Sun W, Yao L, Sun L, Liu L, Ma J, Wang L. Effect of omega-3 fatty acid supplementation on serum lipids and vascular inflammation in patients with end-stage renal disease: a meta-analysis. Sci Rep. 2016 Dec 23;6:39346. doi: 10.1038/srep39346.</citation>
    <PMID>28008943</PMID>
  </reference>
  <reference>
    <citation>Hoogeveen EK, Geleijnse JM, Kromhout D, Stijnen T, Gemen EF, Kusters R, Giltay EJ. Effect of omega-3 fatty acids on kidney function after myocardial infarction: the Alpha Omega Trial. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1676-83. doi: 10.2215/CJN.10441013. Epub 2014 Aug 7.</citation>
    <PMID>25104273</PMID>
  </reference>
  <reference>
    <citation>Malhotra R, Cavanaugh KL, Blot WJ, Ikizler TA, Lipworth L, Kabagambe EK. Dietary polyunsaturated fatty acids and incidence of end-stage renal disease in the Southern Community Cohort Study. BMC Nephrol. 2016 Oct 18;17(1):152. doi: 10.1186/s12882-016-0371-y.</citation>
    <PMID>27756237</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>August 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <results_first_submitted>March 29, 2019</results_first_submitted>
  <results_first_submitted_qc>July 30, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 9, 2019</results_first_posted>
  <last_update_submitted>July 30, 2019</last_update_submitted>
  <last_update_submitted_qc>July 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Chile</investigator_affiliation>
    <investigator_full_name>Daniel Bunout</investigator_full_name>
    <investigator_title>Full profesor</investigator_title>
  </responsible_party>
  <keyword>Albuminuria</keyword>
  <keyword>Carotid Intima-Media Thickness</keyword>
  <keyword>Pulse Wave Velocity</keyword>
  <keyword>Inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Sharing of information must be discussed with the sponsor</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 31, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/15/NCT03280615/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Omega 3 Fatty Acids</title>
          <description>Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks&#xD;
Omega 3 fatty acids: Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids</description>
        </group>
        <group group_id="P2">
          <title>Corn Oil</title>
          <description>Supplementation of 3.7 g of corn oil per day during 12 weeks&#xD;
Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="46"/>
                <participants group_id="P2" count="45"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Omega 3 Fatty Acids</title>
          <description>Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks&#xD;
Omega 3 fatty acids: Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids</description>
        </group>
        <group group_id="B2">
          <title>Corn Oil</title>
          <description>Supplementation of 3.7 g of corn oil per day during 12 weeks&#xD;
Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67" lower_limit="54" upper_limit="74"/>
                    <measurement group_id="B2" value="66" lower_limit="56" upper_limit="74"/>
                    <measurement group_id="B3" value="66" lower_limit="57" upper_limit="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Chile</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Urine albumin excretion</title>
          <units>mg/g creatinine</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="363" lower_limit="157" upper_limit="1030"/>
                    <measurement group_id="B2" value="541" lower_limit="173" upper_limit="1125"/>
                    <measurement group_id="B3" value="455" lower_limit="157" upper_limit="1079"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With a Urine Albumin Excretion Decrease of 20% or More</title>
        <description>Number of participants in whom urine albumin excretion in a spot urine sample at the end of follow up, expressed as mg/g creatinine, decreased by 20% or more</description>
        <time_frame>At baseline and 12 weeks of intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omega 3 Fatty Acids</title>
            <description>Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks&#xD;
Omega 3 fatty acids: Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids</description>
          </group>
          <group group_id="O2">
            <title>Corn Oil</title>
            <description>Supplementation of 3.7 g of corn oil per day during 12 weeks&#xD;
Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With a Urine Albumin Excretion Decrease of 20% or More</title>
          <description>Number of participants in whom urine albumin excretion in a spot urine sample at the end of follow up, expressed as mg/g creatinine, decreased by 20% or more</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A Fisher exact test was performed</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.257</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in C Reactive Protein Levels at 12 Weeks of Intervention</title>
        <description>Blood C reactive protein measured at baseline and the end of the intervention.</description>
        <time_frame>At baseline and 12 weeks of intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omega 3 Fatty Acids</title>
            <description>Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks&#xD;
Omega 3 fatty acids: Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids</description>
          </group>
          <group group_id="O2">
            <title>Corn Oil</title>
            <description>Supplementation of 3.7 g of corn oil per day during 12 weeks&#xD;
Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement</description>
          </group>
        </group_list>
        <measure>
          <title>Change in C Reactive Protein Levels at 12 Weeks of Intervention</title>
          <description>Blood C reactive protein measured at baseline and the end of the intervention.</description>
          <units>mg/L</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="1.5" upper_limit="5.3"/>
                    <measurement group_id="O2" value="1.7" lower_limit="1.1" upper_limit="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>end of follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" lower_limit="1.2" upper_limit="5.9"/>
                    <measurement group_id="O2" value="1.9" lower_limit="1" upper_limit="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groups</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.231</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Pulse Wave Velocity at 12 Weeks of Intervention</title>
        <description>Measurement of pulse wave velocity using a oscillometric device measured at baseline and end of follow up and expressed ad m/s</description>
        <time_frame>At baseline and 12 weeks of intervention</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Omega 3 Fatty Acids</title>
            <description>Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks&#xD;
Omega 3 fatty acids: Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids</description>
          </group>
          <group group_id="O2">
            <title>Corn Oil</title>
            <description>Supplementation of 3.7 g of corn oil per day during 12 weeks&#xD;
Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Pulse Wave Velocity at 12 Weeks of Intervention</title>
          <description>Measurement of pulse wave velocity using a oscillometric device measured at baseline and end of follow up and expressed ad m/s</description>
          <units>m/s</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="46"/>
                <count group_id="O2" value="45"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.8" lower_limit="8.1" upper_limit="10.6"/>
                    <measurement group_id="O2" value="9.3" lower_limit="8.5" upper_limit="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>end of follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.1" lower_limit="8" upper_limit="10.9"/>
                    <measurement group_id="O2" value="9.7" lower_limit="8.3" upper_limit="11.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A mixed linear regression model for repeated measures was performed to test if the outcome behaved differently in both treatment groups</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.043</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Three months of follow up</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Omega 3 Fatty Acids</title>
          <description>Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks&#xD;
Omega 3 fatty acids: Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids</description>
        </group>
        <group group_id="E2">
          <title>Corn Oil</title>
          <description>Supplementation of 3.7 g of corn oil per day during 12 weeks&#xD;
Corn oil: Corn oil will be the placebo comparator for omega 3 fatty acids supplement</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Cervical mass</sub_title>
                <description>Cervical mass</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Started dialysis</sub_title>
                <description>Started dialysis due to terminal renal failure</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Hyperkalemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea, vomiting or diarrhea</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="50"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Product Issues</title>
            <event_list>
              <event>
                <sub_title>Minor complaints</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="50"/>
                <counts group_id="E2" events="36" subjects_affected="36" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Francisco Perez Bravo, Director</name_or_title>
      <organization>Institute of Nutrition and Food Technology University of Chile</organization>
      <phone>+5629781411</phone>
      <email>fperez@inta.uchile.cl</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03280615
org study id: Omegarenal
nct id: NCT03280615
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To study the tolerance and efficacy of an omega 3 fatty acids supplement on renal and
      vascular function and inflammatory parameters in patients with chronic renal disease
In a double blind trial in patients with chronic renal disease, the effects of a 3.7 g
      supplement of docosahexanoic and eicosapentanoic acids or a supplement of a similar dose of
      corn oil during 12 weeks, will be assessed on the following parameters:

        1. Urine albumin excretion

        2. Renal function measured with serum creatinine, cystatin C and beta-2 microglobulin

        3. Carotid intima media thickness and pulse wave velocity

        4. Inflammation status assessed measuring serum levels of C reactive protein and
           interleukin 6

        5. Metabolic control of diabetes

        6. Serum lipid levels
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be randomly selected to receive 3.7 g of a supplement containing docosahexanoic and eicosapentanoic acids or a supplement containing corn oil. The supplements will be provided for 12 weeks
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: Identical sachets containind the study supplement or corn oil will be number coded and provided to participants
measure: Number of Participants With a Urine Albumin Excretion Decrease of 20% or More
time frame: At baseline and 12 weeks of intervention
description: Number of participants in whom urine albumin excretion in a spot urine sample at the end of follow up, expressed as mg/g creatinine, decreased by 20% or more
measure: Change in C Reactive Protein Levels at 12 Weeks of Intervention
time frame: At baseline and 12 weeks of intervention
description: Blood C reactive protein measured at baseline and the end of the intervention.
measure: Change in Pulse Wave Velocity at 12 Weeks of Intervention
time frame: At baseline and 12 weeks of intervention
description: Measurement of pulse wave velocity using a oscillometric device measured at baseline and end of follow up and expressed ad m/s
arm group label: Omega 3 fatty acids
arm group type: Experimental
description: Supplementation of 3.7 g of docosahexanoic and eicosapentanoic acids per day during 12 weeks
arm group label: Corn oil
arm group type: Placebo Comparator
description: Supplementation of 3.7 g of corn oil per day during 12 weeks
intervention type: Dietary Supplement
intervention name: Omega 3 fatty acids
description: Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids
arm group label: Omega 3 fatty acids
intervention type: Dietary Supplement
intervention name: Corn oil
description: Corn oil will be the placebo comparator for omega 3 fatty acids supplement
arm group label: Corn oil
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Chile
citation: Shapiro H, Theilla M, Attal-Singer J, Singer P. Effects of polyunsaturated fatty acid consumption in diabetic nephropathy. Nat Rev Nephrol. 2011 Feb;7(2):110-21. doi: 10.1038/nrneph.2010.156. Epub 2010 Dec 7.
PMID: 21135888
citation: Borg M, Svensson M, Povlsen JV, Schmidt EB, Aalkjaer C, Christensen JH, Ivarsen P. Long chain n-3 polyunsaturated fatty acids and vascular function in patients with chronic kidney disease and healthy subjects: a cross-sectional and comparative study. BMC Nephrol. 2016 Nov 21;17(1):184. doi: 10.1186/s12882-016-0393-5.
PMID: 27871238
citation: Xu T, Sun Y, Sun W, Yao L, Sun L, Liu L, Ma J, Wang L. Effect of omega-3 fatty acid supplementation on serum lipids and vascular inflammation in patients with end-stage renal disease: a meta-analysis. Sci Rep. 2016 Dec 23;6:39346. doi: 10.1038/srep39346.
PMID: 28008943
citation: Hoogeveen EK, Geleijnse JM, Kromhout D, Stijnen T, Gemen EF, Kusters R, Giltay EJ. Effect of omega-3 fatty acids on kidney function after myocardial infarction: the Alpha Omega Trial. Clin J Am Soc Nephrol. 2014 Oct 7;9(10):1676-83. doi: 10.2215/CJN.10441013. Epub 2014 Aug 7.
PMID: 25104273
citation: Malhotra R, Cavanaugh KL, Blot WJ, Ikizler TA, Lipworth L, Kabagambe EK. Dietary polyunsaturated fatty acids and incidence of end-stage renal disease in the Southern Community Cohort Study. BMC Nephrol. 2016 Oct 18;17(1):152. doi: 10.1186/s12882-016-0371-y.
PMID: 27756237
responsible party type: Principal Investigator
investigator affiliation: University of Chile
investigator full name: Daniel Bunout
investigator title: Full profesor
mesh term: Renal Insufficiency
mesh term: Renal Insufficiency, Chronic
mesh term: Kidney Failure, Chronic
sharing ipd: Undecided
ipd description: Sharing of information must be discussed with the sponsor
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 