<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/NCT03825393</url>
  </required_header>
  <id_info>
    <org_study_id>123456</org_study_id>
    <nct_id>NCT03825393</nct_id>
  </id_info>
  <brief_title>Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome</brief_title>
  <official_title>Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tokat State Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tokat State Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      The aim of the present study was to evaluate the association between ferritin levels and&#xD;
      clinical parameters in patients with fibromyalgia syndrome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This sectional study included 100 patients with non-anemic FMS diagnosis and 100 patients&#xD;
      with non anemic non FMS diagnosis whose ferritin levels were measured within the last four&#xD;
      weeks. The participants were evaluated using Fibromyalgia Impact Questionnaire (FIQ), Beck&#xD;
      Anxiety Inventory (BAI), Beck Depression Inventory (BDI) and Pittsburg Sleep Quality Index&#xD;
      (PSQI) as well as with a questionnaire form about descriptive characteristics. Serum ferritin&#xD;
      level of &lt;30 ng/mL was considered iron deficiency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pitsburgh Sleep Quality Index</measure>
    <time_frame>1 year</time_frame>
    <description>Pittsburgh Sleep Quality Index (PSQI) is an 18-item questionnaire measuring sleep quality and disorders in a time period of one month. PSQI measures subjective sleep quality, duration and latency of sleep, sleep disorders, habitual sleep efficiency, daytime dysfunction and use of medication for sleeping. PSQI distinguishes &quot;poor&quot; sleep from &quot;good&quot; sleep.&#xD;
minimum score 1 maximum score 9&#xD;
≥5 total points in PSQI mean &quot;poor&quot; sleep. &lt;5 total points in PSQI mean good sleep.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ferritin Level</measure>
    <time_frame>1 year</time_frame>
    <description>Iron deficiency marker</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fibromyalgia Impact Questionnarie Scores</measure>
    <time_frame>1 year</time_frame>
    <description>Fibromyalgia Impact Questionnaire (FIQ) is a 10-item evaluation tool developed to measure status, prognosis and outcomes of FMS patients. Total points vary from 0 to 100. Higher points show the effect of FMS on functionality.&#xD;
mimimum score 0 maximum score 100 higher scores shows poor functionality.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory</measure>
    <time_frame>1 year</time_frame>
    <description>Beck Depression Inventory (BDI) is a 21-item questionnaire evaluating the presence and severity of depression. Higher points mean heavier depression (0-9 points: minimum depression; 10-18 points: slight depression; 19-29 points: moderate depression; 30-63 points: severe depression).&#xD;
minimum 0 maximum 63 points higher scores mean worse outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Anxiety Inventory</measure>
    <time_frame>1 year</time_frame>
    <description>Beck Anxiety Inventory is a short, easily applied and graded, 21-item questionnaire to evaluate the severity of patients' anxiety. Total points vary from 0 to 63 (0-9 points: normal; 10-18 points: slight to moderate anxiety; 19-29 points: moderate to severe anxiety and 30-63 points: very severe anxiety).&#xD;
minimum 0 maximum 63 points higher scores mean worse outcome</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Fibromyalgia</condition>
  <arm_group>
    <arm_group_label>Fibromyalgia</arm_group_label>
    <description>Non-anemic FMS patients who were diagnosed based on 2011 FMS diagnostic criteria of the American Rheumatology College</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Non-anemic women without a FMS diagnosis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This sectional study included 100 female patients older than 18 years of age who presented&#xD;
        to Physical Treatment and Rehabilitation polyclinic in 2016-17 period.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Fibromyalgi syndrome patients&#xD;
&#xD;
          -  ferritin levels were measured within the last four weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  parenteral or enteral iron usage in last four weeks&#xD;
&#xD;
          -  hemoglobin level was less than 12 g/dl&#xD;
&#xD;
          -  infection&#xD;
&#xD;
          -  malignity&#xD;
&#xD;
          -  active inflammatory arthritis&#xD;
&#xD;
          -  serious skin variations&#xD;
&#xD;
          -  serious peripheral vascular disease&#xD;
&#xD;
          -  iron storing disorder&#xD;
&#xD;
          -  pregnant or lactating patients&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>sevil okan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Doctor</affiliation>
  </overall_official>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 26, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <results_first_submitted>May 26, 2019</results_first_submitted>
  <results_first_submitted_qc>April 4, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 7, 2020</results_first_posted>
  <last_update_submitted>April 4, 2020</last_update_submitted>
  <last_update_submitted_qc>April 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tokat State Hospital</investigator_affiliation>
    <investigator_full_name>Sevil Okan</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>Fibromyalgia Syndrome, Ferritin, Sleep</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>March 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/93/NCT03825393/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Fibromiyalgia</title>
          <description>100 Fibromyalgia Patient Group</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>100 Control Group</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
                <participants group_id="P2" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Fibromiyalgia</title>
          <description>100 Fibromyalgia Patient Group</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>100 Control Group</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="100"/>
            <count group_id="B2" value="100"/>
            <count group_id="B3" value="200"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</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>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <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>Count of Participants</param>
          <class_list>
            <class>
              <title>Turkey</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ferritin level</title>
          <units>ng/ml</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="100"/>
                    <count group_id="B2" value="100"/>
                    <count group_id="B3" value="200"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20.95" lower_limit="11.75" upper_limit="39.55"/>
                    <measurement group_id="B2" value="34.91" lower_limit="17.87" upper_limit="55.12"/>
                    <measurement group_id="B3" value="32.92" lower_limit="14.65" upper_limit="47.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pitsburgh Sleep Quality Index</title>
        <description>Pittsburgh Sleep Quality Index (PSQI) is an 18-item questionnaire measuring sleep quality and disorders in a time period of one month. PSQI measures subjective sleep quality, duration and latency of sleep, sleep disorders, habitual sleep efficiency, daytime dysfunction and use of medication for sleeping. PSQI distinguishes &quot;poor&quot; sleep from &quot;good&quot; sleep.&#xD;
minimum score 1 maximum score 9&#xD;
≥5 total points in PSQI mean &quot;poor&quot; sleep. &lt;5 total points in PSQI mean good sleep.</description>
        <time_frame>1 year</time_frame>
        <population>100 This index applied only Firomyalgia syndrome group</population>
        <group_list>
          <group group_id="O1">
            <title>Fibromyalgia</title>
            <description>Fibromyalgia syndrome group</description>
          </group>
        </group_list>
        <measure>
          <title>Pitsburgh Sleep Quality Index</title>
          <description>Pittsburgh Sleep Quality Index (PSQI) is an 18-item questionnaire measuring sleep quality and disorders in a time period of one month. PSQI measures subjective sleep quality, duration and latency of sleep, sleep disorders, habitual sleep efficiency, daytime dysfunction and use of medication for sleeping. PSQI distinguishes &quot;poor&quot; sleep from &quot;good&quot; sleep.&#xD;
minimum score 1 maximum score 9&#xD;
≥5 total points in PSQI mean &quot;poor&quot; sleep. &lt;5 total points in PSQI mean good sleep.</description>
          <population>100 This index applied only Firomyalgia syndrome group</population>
          <units>score on a questionnarie</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.3" spread="3.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Ferritin Level</title>
        <description>Iron deficiency marker</description>
        <time_frame>1 year</time_frame>
        <population>200</population>
        <group_list>
          <group group_id="O1">
            <title>Control</title>
            <description>Control Group</description>
          </group>
          <group group_id="O2">
            <title>Fibromyalgia</title>
            <description>Fibromyalgia syndrome</description>
          </group>
        </group_list>
        <measure>
          <title>Ferritin Level</title>
          <description>Iron deficiency marker</description>
          <population>200</population>
          <units>ng/ml</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="100"/>
                <count group_id="O2" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.91" lower_limit="17.87" upper_limit="55.12"/>
                    <measurement group_id="O2" value="20.95" lower_limit="11.75" upper_limit="39.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fibromyalgia Impact Questionnarie Scores</title>
        <description>Fibromyalgia Impact Questionnaire (FIQ) is a 10-item evaluation tool developed to measure status, prognosis and outcomes of FMS patients. Total points vary from 0 to 100. Higher points show the effect of FMS on functionality.&#xD;
mimimum score 0 maximum score 100 higher scores shows poor functionality.</description>
        <time_frame>1 year</time_frame>
        <population>100 This questionnarie applied only Firomyalgia syndrome group</population>
        <group_list>
          <group group_id="O1">
            <title>Fibromiyalgia</title>
            <description>100 Fibromyalgia Patient Group 100 Control Group</description>
          </group>
        </group_list>
        <measure>
          <title>Fibromyalgia Impact Questionnarie Scores</title>
          <description>Fibromyalgia Impact Questionnaire (FIQ) is a 10-item evaluation tool developed to measure status, prognosis and outcomes of FMS patients. Total points vary from 0 to 100. Higher points show the effect of FMS on functionality.&#xD;
mimimum score 0 maximum score 100 higher scores shows poor functionality.</description>
          <population>100 This questionnarie applied only Firomyalgia syndrome group</population>
          <units>score on a questionnarie</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="61.69" spread="17.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Depression Inventory</title>
        <description>Beck Depression Inventory (BDI) is a 21-item questionnaire evaluating the presence and severity of depression. Higher points mean heavier depression (0-9 points: minimum depression; 10-18 points: slight depression; 19-29 points: moderate depression; 30-63 points: severe depression).&#xD;
minimum 0 maximum 63 points higher scores mean worse outcome.</description>
        <time_frame>1 year</time_frame>
        <population>100 This questionnarie applied only Firomyalgia syndrome group</population>
        <group_list>
          <group group_id="O1">
            <title>Fibromiyalgia</title>
            <description>100 Fibromyalgia Patient Group 100 Control Group</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Depression Inventory</title>
          <description>Beck Depression Inventory (BDI) is a 21-item questionnaire evaluating the presence and severity of depression. Higher points mean heavier depression (0-9 points: minimum depression; 10-18 points: slight depression; 19-29 points: moderate depression; 30-63 points: severe depression).&#xD;
minimum 0 maximum 63 points higher scores mean worse outcome.</description>
          <population>100 This questionnarie applied only Firomyalgia syndrome group</population>
          <units>score on a questionnarie</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.73" spread="9.76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Beck Anxiety Inventory</title>
        <description>Beck Anxiety Inventory is a short, easily applied and graded, 21-item questionnaire to evaluate the severity of patients' anxiety. Total points vary from 0 to 63 (0-9 points: normal; 10-18 points: slight to moderate anxiety; 19-29 points: moderate to severe anxiety and 30-63 points: very severe anxiety).&#xD;
minimum 0 maximum 63 points higher scores mean worse outcome</description>
        <time_frame>1 year</time_frame>
        <population>100 This inventory applied only Firomyalgia syndrome group</population>
        <group_list>
          <group group_id="O1">
            <title>Fibromiyalgia</title>
            <description>100 Fibromyalgia Patient Group 100 Control Group</description>
          </group>
        </group_list>
        <measure>
          <title>Beck Anxiety Inventory</title>
          <description>Beck Anxiety Inventory is a short, easily applied and graded, 21-item questionnaire to evaluate the severity of patients' anxiety. Total points vary from 0 to 63 (0-9 points: normal; 10-18 points: slight to moderate anxiety; 19-29 points: moderate to severe anxiety and 30-63 points: very severe anxiety).&#xD;
minimum 0 maximum 63 points higher scores mean worse outcome</description>
          <population>100 This inventory applied only Firomyalgia syndrome group</population>
          <units>score on a questionnarie</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.58" spread="11.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>no advers event 1 year</time_frame>
      <desc>no advers event</desc>
      <group_list>
        <group group_id="E1">
          <title>Fibromiyalgia</title>
          <description>100 Fibromyalgia Patient Group</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>100 Control Group</description>
        </group>
      </group_list>
      <serious_events>
        <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="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="100"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Association of Ferritin Levels With Clinical Parameters in Patients With Fibromyalgia Syndrome</name_or_title>
      <organization>Tokat State Hospital</organization>
      <phone>5308211797</phone>
      <email>doctorsevil@yahoo.com</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/NCT03825393
org study id: 123456
nct id: NCT03825393
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the present study was to evaluate the association between ferritin levels and
      clinical parameters in patients with fibromyalgia syndrome.
This sectional study included 100 patients with non-anemic FMS diagnosis and 100 patients
      with non anemic non FMS diagnosis whose ferritin levels were measured within the last four
      weeks. The participants were evaluated using Fibromyalgia Impact Questionnaire (FIQ), Beck
      Anxiety Inventory (BAI), Beck Depression Inventory (BDI) and Pittsburg Sleep Quality Index
      (PSQI) as well as with a questionnaire form about descriptive characteristics. Serum ferritin
      level of <30 ng/mL was considered iron deficiency.
observational model: Case-Control
time perspective: Retrospective
measure: Pitsburgh Sleep Quality Index
time frame: 1 year
description: Pittsburgh Sleep Quality Index (PSQI) is an 18-item questionnaire measuring sleep quality and disorders in a time period of one month. PSQI measures subjective sleep quality, duration and latency of sleep, sleep disorders, habitual sleep efficiency, daytime dysfunction and use of medication for sleeping. PSQI distinguishes "poor" sleep from "good" sleep.
minimum score 1 maximum score 9
≥5 total points in PSQI mean "poor" sleep. <5 total points in PSQI mean good sleep.
measure: Ferritin Level
time frame: 1 year
description: Iron deficiency marker
measure: Fibromyalgia Impact Questionnarie Scores
time frame: 1 year
description: Fibromyalgia Impact Questionnaire (FIQ) is a 10-item evaluation tool developed to measure status, prognosis and outcomes of FMS patients. Total points vary from 0 to 100. Higher points show the effect of FMS on functionality.
mimimum score 0 maximum score 100 higher scores shows poor functionality.
measure: Beck Depression Inventory
time frame: 1 year
description: Beck Depression Inventory (BDI) is a 21-item questionnaire evaluating the presence and severity of depression. Higher points mean heavier depression (0-9 points: minimum depression; 10-18 points: slight depression; 19-29 points: moderate depression; 30-63 points: severe depression).
minimum 0 maximum 63 points higher scores mean worse outcome.
measure: Beck Anxiety Inventory
time frame: 1 year
description: Beck Anxiety Inventory is a short, easily applied and graded, 21-item questionnaire to evaluate the severity of patients' anxiety. Total points vary from 0 to 63 (0-9 points: normal; 10-18 points: slight to moderate anxiety; 19-29 points: moderate to severe anxiety and 30-63 points: very severe anxiety).
minimum 0 maximum 63 points higher scores mean worse outcome
arm group label: Fibromyalgia
description: Non-anemic FMS patients who were diagnosed based on 2011 FMS diagnostic criteria of the American Rheumatology College
arm group label: Control
description: Non-anemic women without a FMS diagnosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: sevil okan
role: Principal Investigator
affiliation: Doctor
responsible party type: Principal Investigator
investigator affiliation: Tokat State Hospital
investigator full name: Sevil Okan
investigator title: principal investigator
mesh term: Fibromyalgia
mesh term: Myofascial Pain Syndromes
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 