Gulf War Illness: Evaluation of an Innovative Detoxification Program
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pilot Study of Application of the Hubbard Detoxification Program to Veterans With Gulf War Illness|
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
- 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. ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Experimental: Hubbard detoxification program
Daily mild-moderate exercise for 20 minutes, intermittent Finnish saunas at 140'F for approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses per Hubbard protocol.
Other: Hubbard detoxification program
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.
No Intervention: Usual Care
Veterans with Gulf War illness continue with usual medical management as required.
This will be a randomized controlled trial of 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:
- 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 GWI will be measured with the Kansas Gulf War Veterans Health Project Questionnaire, the Multidimensional Fatigue Inventory, and the short-form McGill Pain 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 measured 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. 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01672710
|Contact: Crystal Grant, Ph.Dfirstname.lastname@example.org|
|Contact: David O Carpenter, MDemail@example.com|
|United States, Maryland|
|Severna Park Health and Wellness Center||Recruiting|
|Annapolis, Maryland, United States, 21401|
|Contact: Crystal Grant, PhD 617-217-0128 firstname.lastname@example.org|
|Contact: David O Carpenter, MD 518-525-2660 email@example.com|
|Principal Investigator: David O Carpenter, MD|
|Principal Investigator:||David O Carpenter, MD||University at Albany|