<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/NCT01672710</url>
  </required_header>
  <id_info>
    <org_study_id>GW093066</org_study_id>
    <nct_id>NCT01672710</nct_id>
  </id_info>
  <brief_title>Gulf War Illness: Evaluation of an Innovative Detoxification Program</brief_title>
  <official_title>Pilot Study of Application of the Hubbard Detoxification Program to Veterans With Gulf War Illness</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University at Albany</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Sage Colleges</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Women's College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Severna Park Health and Wellness Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University at Albany</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Gulf War illness is found in about one fourth of veterans of the 1990-1991 Gulf War and is&#xD;
      characterized by persistent memory and concentration problems, headaches, fatigue and muscle&#xD;
      and joint pain. It is not known what causes the illness, but exposure to chemicals is&#xD;
      suspected. The Hubbard detoxification program consists of exercise and sauna therapy together&#xD;
      with administration of several dietary supplements, particularly crystalline niacin used at&#xD;
      increasing concentrations over a period of about four weeks. The investigators hypothesize&#xD;
      that this program will reduce symptoms, as tested by administration of cognitive and quality&#xD;
      of life tests and serum clinical chemistry tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a pilot randomized controlled trial of feasibility, safety and changes in&#xD;
      fatigue and pain symptoms, measured quality of life, mental health status, and&#xD;
      neuro-cognitive functioning of a group of GWVs after a 4 to 6 week sauna detoxification&#xD;
      regimen as compared to control. For control subjects we will also have a group of GWVs&#xD;
      receiving usual care who are randomly assigned to a waitlist and who will start the&#xD;
      intervention after a four to six week delay. The waitlist group will also take part in the&#xD;
      baseline tests a second time just prior to their treatment 4 to 6 weeks later and a 7-day&#xD;
      post-treatment battery of tests the same as described for the treatment group. Finally, there&#xD;
      will be a 3-month follow-up with both the groups. The Severna Park Health and Wellness Center&#xD;
      (SPHWC) is a commercial center that offers the Hubbard detoxification program. The&#xD;
      investigators will contract with SPHWC to provide the program to the subjects of this study&#xD;
      and to provide office space for the Study Coordinator, so that all components of this project&#xD;
      except the initial Physician evaluation and blood sample acquisition can be done at the&#xD;
      Center, not just the detoxification.&#xD;
&#xD;
      Study Variables: The investigators will examine feasibility of the research design, and&#xD;
      safety of the regimen and estimate changes in:&#xD;
&#xD;
        -  Quality of life as measured by the Veterans Short Form (SF36-V). The SF36-V also&#xD;
           includes physical (PCS) and mental (MCS) component summary scores.&#xD;
&#xD;
        -  Case status for GWI will be assessed utilizing the Kansas criteria.&#xD;
&#xD;
        -  Symptoms of fatigue and pain in GWI will be measured wit, the Multidimensional Fatigue&#xD;
           Inventory, and the short-form McGill Pain-2 Questionnaire.&#xD;
&#xD;
        -  Cognitive function will be measured with a battery of neurocognitive tests. These will&#xD;
           include visual motor, memory and executive functioning as measured by the Trailmaking&#xD;
           test, Grooved Pegboard, Wechsler Memory Abbreviated test, and the Stroop color word&#xD;
           test. To account for potential confounding in neurocognitive testing, mental health&#xD;
           status will be evaluated using the Symptom Checklist 90 revised and the State Trait&#xD;
           Anxiety Inventory.&#xD;
&#xD;
        -  Physical health status will be assessed via standard medical examination and laboratory&#xD;
           analyses of serum metabolic panel, lipid profile and hormones.&#xD;
&#xD;
      Sampling Method: This will be a convenience sample and will consist of Gulf War Veterans who&#xD;
      meet the Kansas case definition for Gulf War illness and reside in the Washington/Baltimore&#xD;
      area or can travel to and reside in the area for several weeks. The individuals who show&#xD;
      interest in this study, who meet eligibility criteria and subsequently agree to participate&#xD;
      will be selected to enroll in the study.&#xD;
&#xD;
      Randomization: Volunteers will be randomly assigned to a group when they enroll. One group&#xD;
      will be the immediate experimental intervention group and one group will be the wait-list&#xD;
      control group. Random assignment will be achieved by use of sequentially numbered, opaque,&#xD;
      sealed envelopes. Both will undergo the detoxification protocol, but the control group will&#xD;
      be tested twice prior to treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2010</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Pilot</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short Form-36 for Veterans Quality of Life Physical Component Summary Scores</measure>
    <time_frame>baseline, 5 weeks</time_frame>
    <description>Qualify of life will be determined per Short Form-36 for veterans quality of life Physical component (PCS) summary scales, range from 0 to 100 with 100 being better; 50 is expected population average.&#xD;
immediate intervention and waitlist groups changes compared from baseline and adjusted mean differences at end of 5 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fatigue Severity</measure>
    <time_frame>baseline, 5 weeks</time_frame>
    <description>Multidimensional fatigue inventory. change in Self reported fatigue severity. Measures 5 dimensions of fatigue: general, physical, mental, reduced motivation and reduced activity. Scores 4-20 in each dimension, higher score worse fatigue.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Gulf War Illness</condition>
  <arm_group>
    <arm_group_label>regimen of niacin, exercise, sauna,</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>4-5 week daily sauna, exercise and niacin with other supplements</description>
  </arm_group>
  <arm_group>
    <arm_group_label>waitlist</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>4 week waitlist with treatment as usual</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>plain crystalline niacin, exercise, sauna</intervention_name>
    <description>A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.</description>
    <arm_group_label>regimen of niacin, exercise, sauna,</arm_group_label>
    <arm_group_label>waitlist</arm_group_label>
    <other_name>Hubbard detoxification program</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any veteran of the 1990-1991 Gulf War who meets the Kansas Gulf War Illness case&#xD;
             definition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Veterans who meet the inclusion criteria but have been diagnosed by a physician with&#xD;
             (1) chronic conditions (eg., cancer, heart disease, diabetes, liver disease, multiple&#xD;
             sclerosis, etc.) that are not associated with Gulf War service but can produce diverse&#xD;
             symptoms similar to Gulf War Illness; (2) conditions that might interfere with&#xD;
             respondents' ability to report symptoms (eg., psychiatric conditions or history of&#xD;
             hospitalization for depression, alcohol or drug dependence; (3) pregnancy or&#xD;
             unwillingness to use contraception.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David O Carpenter, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University at Albany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Severna Park Health and Wellness Center</name>
      <address>
        <city>Annapolis</city>
        <state>Maryland</state>
        <zip>21401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <results_first_submitted>July 31, 2018</results_first_submitted>
  <results_first_submitted_qc>December 22, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">December 28, 2018</results_first_posted>
  <last_update_submitted>April 6, 2020</last_update_submitted>
  <last_update_submitted_qc>April 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University at Albany</investigator_affiliation>
    <investigator_full_name>David O. Carpenter</investigator_full_name>
    <investigator_title>Director, Institute for Health and the Environment, University at Albany</investigator_title>
  </responsible_party>
  <keyword>Hubbard detoxification</keyword>
  <keyword>Exercise</keyword>
  <keyword>Sauna therapy</keyword>
  <keyword>Niacin</keyword>
  <keyword>Gulf War illness</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Niacin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Niacin, Exercise, Sauna,</title>
          <description>plain crystalline niacin, exercise, sauna: A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.</description>
        </group>
        <group group_id="P2">
          <title>no Intervention</title>
          <description>waitlisted group receives treatment as usual for 4 weeks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Controlled Comparison 5 Week Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22">sauna intervention group repeat all assessments 7 days after complete the regimen</participants>
                <participants group_id="P2" count="10">waitlist group repeat baseline assessments after 4 week time period then begin sauna</participants>
              </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>
          <title>Waitlist Assessed After Sauna Regimen</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22">immediate start group no further assessments until 3 month follow up</participants>
                <participants group_id="P2" count="10">waitlisted group receive the 4 week intervention and complete 7 day assessments</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22">non applicable, cannot compare the immediate start and waitlist in this period</participants>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>3 Month Follow up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="4"/>
              </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="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>follow up due after termination date</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Niacin, Exercise, Sauna,</title>
          <description>plain crystalline niacin, exercise, sauna: A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.</description>
        </group>
        <group group_id="B2">
          <title>no Intervention</title>
          <description>treatment as usual for 4 weeks</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="22"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <description>in years</description>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51.7" spread="7.9"/>
                    <measurement group_id="B2" value="50.2" spread="5.5"/>
                    <measurement group_id="B3" value="51.2" spread="7.2"/>
                  </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="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Short Form-36 for Veterans Quality of Life Physical Component Summary Scores</title>
        <description>Qualify of life will be determined per Short Form-36 for veterans quality of life Physical component (PCS) summary scales, range from 0 to 100 with 100 being better; 50 is expected population average.&#xD;
immediate intervention and waitlist groups changes compared from baseline and adjusted mean differences at end of 5 weeks.</description>
        <time_frame>baseline, 5 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Niacin, Exercise, Sauna,</title>
            <description>plain crystalline niacin, exercise, sauna: A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.</description>
          </group>
          <group group_id="O2">
            <title>no Intervention</title>
          </group>
        </group_list>
        <measure>
          <title>Short Form-36 for Veterans Quality of Life Physical Component Summary Scores</title>
          <description>Qualify of life will be determined per Short Form-36 for veterans quality of life Physical component (PCS) summary scales, range from 0 to 100 with 100 being better; 50 is expected population average.&#xD;
immediate intervention and waitlist groups changes compared from baseline and adjusted mean differences at end of 5 weeks.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline PCS score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30.3" spread="8.9"/>
                    <measurement group_id="O2" value="36.7" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 week PCS scores</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.2" spread="10.3"/>
                    <measurement group_id="O2" value="35.7" spread="12.1"/>
                  </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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.05</p_value>
            <method>ANCOVA</method>
            <param_type>Mean Difference (Net)</param_type>
            <param_value>6.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.3</ci_lower_limit>
            <ci_upper_limit>14.2</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Fatigue Severity</title>
        <description>Multidimensional fatigue inventory. change in Self reported fatigue severity. Measures 5 dimensions of fatigue: general, physical, mental, reduced motivation and reduced activity. Scores 4-20 in each dimension, higher score worse fatigue.</description>
        <time_frame>baseline, 5 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Niacin, Exercise, Sauna,</title>
            <description>plain crystalline niacin, exercise, sauna: A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.</description>
          </group>
          <group group_id="O2">
            <title>no Intervention</title>
          </group>
        </group_list>
        <measure>
          <title>Fatigue Severity</title>
          <description>Multidimensional fatigue inventory. change in Self reported fatigue severity. Measures 5 dimensions of fatigue: general, physical, mental, reduced motivation and reduced activity. Scores 4-20 in each dimension, higher score worse fatigue.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline fatigue score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.4" spread="2.6"/>
                    <measurement group_id="O2" value="15.3" spread="5.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 week fatigue score</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" spread="4.8"/>
                    <measurement group_id="O2" value="15.7" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>4-6 weeks</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Niacin, Exercise, Sauna</title>
          <description>the immediate intervention group (n=22) completed the step in 4 weeks,</description>
        </group>
        <group group_id="E2">
          <title>no Intervention Waitlist</title>
          <description>received only usual care, followed by (n=10) crossed over to receive the intervention for a 4 week period</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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="3" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>hypotension</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>hypokalemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_at_risk="10"/>
              </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>David O. Carpenter MD</name_or_title>
      <organization>Institute for Health and the Environment, University at Albany</organization>
      <phone>518-525-2660</phone>
      <email>dcarpenter@albany.edu</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/NCT01672710
org study id: GW093066
nct id: NCT01672710
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
Gulf War illness is found in about one fourth of veterans of the 1990-1991 Gulf War and is
      characterized by persistent memory and concentration problems, headaches, fatigue and muscle
      and joint pain. It is not known what causes the illness, but exposure to chemicals is
      suspected. The Hubbard detoxification program consists of exercise and sauna therapy together
      with administration of several dietary supplements, particularly crystalline niacin used at
      increasing concentrations over a period of about four weeks. The investigators hypothesize
      that this program will reduce symptoms, as tested by administration of cognitive and quality
      of life tests and serum clinical chemistry tests.
This will be a pilot randomized controlled trial of feasibility, safety and changes in
      fatigue and pain symptoms, measured quality of life, mental health status, and
      neuro-cognitive functioning of a group of GWVs after a 4 to 6 week sauna detoxification
      regimen as compared to control. For control subjects we will also have a group of GWVs
      receiving usual care who are randomly assigned to a waitlist and who will start the
      intervention after a four to six week delay. The waitlist group will also take part in the
      baseline tests a second time just prior to their treatment 4 to 6 weeks later and a 7-day
      post-treatment battery of tests the same as described for the treatment group. Finally, there
      will be a 3-month follow-up with both the groups. The Severna Park Health and Wellness Center
      (SPHWC) is a commercial center that offers the Hubbard detoxification program. The
      investigators will contract with SPHWC to provide the program to the subjects of this study
      and to provide office space for the Study Coordinator, so that all components of this project
      except the initial Physician evaluation and blood sample acquisition can be done at the
      Center, not just the detoxification.

      Study Variables: The investigators will examine feasibility of the research design, and
      safety of the regimen and estimate changes in:

        -  Quality of life as measured by the Veterans Short Form (SF36-V). The SF36-V also
           includes physical (PCS) and mental (MCS) component summary scores.

        -  Case status for GWI will be assessed utilizing the Kansas criteria.

        -  Symptoms of fatigue and pain in GWI will be measured wit, the Multidimensional Fatigue
           Inventory, and the short-form McGill Pain-2 Questionnaire.

        -  Cognitive function will be measured with a battery of neurocognitive tests. These will
           include visual motor, memory and executive functioning as measured by the Trailmaking
           test, Grooved Pegboard, Wechsler Memory Abbreviated test, and the Stroop color word
           test. To account for potential confounding in neurocognitive testing, mental health
           status will be evaluated using the Symptom Checklist 90 revised and the State Trait
           Anxiety Inventory.

        -  Physical health status will be assessed via standard medical examination and laboratory
           analyses of serum metabolic panel, lipid profile and hormones.

      Sampling Method: This will be a convenience sample and will consist of Gulf War Veterans who
      meet the Kansas case definition for Gulf War illness and reside in the Washington/Baltimore
      area or can travel to and reside in the area for several weeks. The individuals who show
      interest in this study, who meet eligibility criteria and subsequently agree to participate
      will be selected to enroll in the study.

      Randomization: Volunteers will be randomly assigned to a group when they enroll. One group
      will be the immediate experimental intervention group and one group will be the wait-list
      control group. Random assignment will be achieved by use of sequentially numbered, opaque,
      sealed envelopes. Both will undergo the detoxification protocol, but the control group will
      be tested twice prior to treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Pilot
primary purpose: Treatment
masking: None (Open Label)
measure: Short Form-36 for Veterans Quality of Life Physical Component Summary Scores
time frame: baseline, 5 weeks
description: Qualify of life will be determined per Short Form-36 for veterans quality of life Physical component (PCS) summary scales, range from 0 to 100 with 100 being better; 50 is expected population average.
immediate intervention and waitlist groups changes compared from baseline and adjusted mean differences at end of 5 weeks.
measure: Fatigue Severity
time frame: baseline, 5 weeks
description: Multidimensional fatigue inventory. change in Self reported fatigue severity. Measures 5 dimensions of fatigue: general, physical, mental, reduced motivation and reduced activity. Scores 4-20 in each dimension, higher score worse fatigue.
arm group label: regimen of niacin, exercise, sauna,
arm group type: Experimental
description: 4-5 week daily sauna, exercise and niacin with other supplements
arm group label: waitlist
arm group type: Other
description: 4 week waitlist with treatment as usual
intervention type: Drug
intervention name: plain crystalline niacin, exercise, sauna
description: A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.
arm group label: regimen of niacin, exercise, sauna,
arm group label: waitlist
other name: Hubbard detoxification program
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: David O Carpenter, MD
role: Principal Investigator
affiliation: University at Albany
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University at Albany
investigator full name: David O. Carpenter
investigator title: Director, Institute for Health and the Environment, University at Albany
mesh term: Niacin
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 