Gulf War Illness: Evaluation of an Innovative Detoxification Program

• Sponsor: University at Albany
• Collaborators: United States Department of Defense; The Sage Colleges; Women's College Hospital; Severna Park Health and Wellness Center
• Information provided by (Responsible Party): David O. Carpenter, University at Albany

Tracking Information

• First Submitted Date: August 15, 2012
• First Posted Date: August 27, 2012
• Results First Submitted Date: July 31, 2018
• Results First Posted Date: December 28, 2018
• Last Update Posted Date: December 28, 2018
• Study Start Date: April 2010
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 22, 2018)

Short Form-36 for Veterans Quality of Life Physical Component Summary Scores [ Time Frame: baseline, 5 weeks ]

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.

Original Primary Outcome Measures (submitted: August 22, 2012)

Improvement on quality of life measurement [ Time Frame: Subjects will be tested at three points in time for the experimental and four points for the control group. The investigators expect to have completed recruitment of all subjects and obtained all information at the end of no more than two years. ]

Qualify of life will be determined by quality of life tests given before the detoxification program, immediately after and three months after completion of the detoxification program. The hypothesis to be tested is that subjects will report a maintained improved quality of life after completion of the program.

• Change History: Complete list of historical versions of study NCT01672710 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: December 22, 2018)

• Fatigue Severity [ Time Frame: baseline, 5 weeks ]
  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.
• Pain Severity [ Time Frame: baseline, 5 weeks ]
  Short-form McGill Pain Questionnaire revised. Self reported pain severity. Measures sensory and affective perception of pain and total score is calculated from the mean of 22 items. Score 0-10, higher scores more pain.

Original Secondary Outcome Measures (submitted: August 22, 2012)

Improved performance on cognitive function tests [ Time Frame: All cognitive tests will be given at the same schedule as listed above, with tests given at four times for the control group and three for the experimental group. ]

Several cognitive function tests will be given before, immediately after and three months after completion of the program. The hypothesis being tested is that performance will have improved after the program.

Current Other Pre-specified Outcome Measures (submitted: December 22, 2018)

• Feasibility Aspects for Informing Future Multi Center Clinical Trial of This Detoxification Protocol on Ill GW Veterans, [ Time Frame: whole study ]
  patient accrual,retention, compliance with intervention, and any unusual difficulties in providing the intervention in this population.
• Stable Clinical Chemistry Test Parameters [ Time Frame: Blood draws for clinical chemistries will be obtained at each of time points listed above. The investigators expect ot have completed recruitment of all subjects and obtained all information at the end of no more than two years. ]
  All subjects will have blood samples drawn for measurement of comprehensive metabolic panel, lipid panel, complete blood count with differential and thyroid panel before, immediately after and three months after completing the program.
• Veterans SF-36 Change From Baseline in Quality of Life 8 Domains General Health Physical Functioning, Physical Limitations, Bodily Pain, Energy/Vitality, Social Functioning, Emotional Limitations Mental Health and Summary Measures [ Time Frame: baseline, 5 weeks and 3 month ]
  scores on scales, 0-100 being maximum score
• Kansas Gulf War Illness Case Definition [ Time Frame: baseline, 5 weeks and 3 month ]
  presence and severity (mild, moderate, severe) of 30 symptoms in 6 domains,
• Trail Making Test Parts A and B [ Time Frame: baseline, 5 weeks post sauna or waitlist and at 3 month follow up. ]
  Paper and Pencils task. Trail A - Time in seconds to complete alphabet maze. Trail B Time to complete alphabet and numerical maze Measures fine motor functioning and response to complex visual cues. Sensitive indicator of neurological impairment. Trail B- can be an indicator of executive function. decreased time in seconds is better score
• Grooved Pegboard Test [ Time Frame: baseline, 5 weeks post sauna or waitlist and at 3 month follow up. ]
  Timed task with pegs inserted into keyhole type grooves on board.VISUAL MOTOR SKILLS - Measures visual motor skills. Hand and Eye coordination. Indicator of neurological impairment. Decrease time in seconds better score
• Symptom Checklist 90-Revised (SCL-90-R) [ Time Frame: baseline, 5 weeks post sauna or waitlist and at 3 month follow up. ]
  Paper and pencil questionnaire with ninety items. PSYCHOLOGICAL FUNCTION- Measure of psychological functioning with 9 domains: Depression, Anxiety, Psychoticism, Hostility, Interpersonal Sensitivity, Phobic Anxiety, Somatization, Obsessive-Compulsive, Paranoid ideation

Original Other Pre-specified Outcome Measures (submitted: August 22, 2012)

Improved clinical chemistry test parameters [ Time Frame: Blood draws for clinical chemistries will be obtained at each of time points listed above. The investigators expect ot have completed recruitment of all subjects and obtained all information at the end of no more than two years. ]

All subjects will have blood samples drawn for measurement of comprehensive metabolic panel, lipid panel, complete blood count with differential and thyroid panel before, immediately after and three months after completing the program.

Descriptive Information

• Brief Title: Gulf War Illness: Evaluation of an Innovative Detoxification Program
• Official Title: Pilot Study of Application of the Hubbard Detoxification Program to Veterans With Gulf War Illness
• Brief Summary: 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Pilot

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Gulf War Illness

Intervention

Drug: 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.

Other Name: Hubbard detoxification program

Study Arms

• Experimental: regimen of niacin, exercise, sauna,
  4-5 week daily sauna, exercise and niacin with other supplements
  Intervention: Drug: plain crystalline niacin, exercise, sauna
• waitlist
  4 week waitlist with treatment as usual
  Intervention: Drug: plain crystalline niacin, exercise, sauna

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 22, 2018): 32
• Original Estimated Enrollment (submitted: August 22, 2012): 50
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Any veteran of the 1990-1991 Gulf War who meets the Kansas Gulf War Illness case definition.

Exclusion Criteria:

• Veterans who meet the inclusion criteria but have been diagnosed by a physician with (1) chronic conditions (eg., cancer, heart disease, diabetes, liver disease, multiple sclerosis, etc.) that are not associated with Gulf War service but can produce diverse symptoms similar to Gulf War Illness; (2) conditions that might interfere with respondents' ability to report symptoms (eg., psychiatric conditions or history of hospitalization for depression, alcohol or drug dependence; (3) pregnancy or unwillingness to use contraception.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01672710
• Other Study ID Numbers: GW093066
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: David O. Carpenter, University at Albany
• Study Sponsor: University at Albany

Collaborators

• United States Department of Defense
• The Sage Colleges
• Women's College Hospital
• Severna Park Health and Wellness Center

Investigators

• Principal Investigator: David O Carpenter, MD; University at Albany

• PRS Account: University at Albany
• Verification Date: December 2018