Gulf War Illness: Evaluation of an Innovative Detoxification Program
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|ClinicalTrials.gov Identifier: NCT01672710|
Recruitment Status : Completed
First Posted : August 27, 2012
Last Update Posted : July 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gulf War Illness||Drug: plain crystalline niacin, exercise, sauna||Phase 2|
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-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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Application of the Hubbard Detoxification Program to Veterans With Gulf War Illness|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||December 2015|
|Experimental: niacin, exercise, sauna,||
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
|No Intervention: no intervention|
- Short Form-36 for veterans quality of life measurement [ Time Frame: all Subjects will be tested at baseline, at week 5 after intervention or control wait period. control retest after intervention at week 10. all retest 3 months later. (at 16 weeks or 20 weeks) ]Qualify of life will be determined in 8 domains and by Mental component (MCS) and Physical component (PCS) summary scales range from 0 to 100 with 100 being better; 50 is expected population average. The hypothesis to be tested is that scores will increase after the intervention compared to waitlist controls and that they will remain stable at 3 month follow up.
- Kansas Gulf War Veterans case definition questionnaire [ Time Frame: all Subjects will be tested at baseline, at week 5 after intervention or control wait period. control retest after intervention at week 10. all retest 3 months later. (at 16 weeks or 20 weeks) ]presence and severity (mild, moderate, severe) of 30 symptoms in 6 domains: fatigue, pain, neurological/cognitive/mood, skin, gastrointestinal, respiratory, which began after deployment. A score of 2 or greater in at least 3 of 6 domains meets case criteria. The hypothesis to be tested is that scores will decrease after the intervention compared to waitlist controls and that they will remain stable at 3 month follow up.
- Multidimensional Fatigue Inventory (MFI-20) [ Time Frame: all Subjects will be tested at baseline, at week 5 after intervention or control wait period. control retest after intervention at week 10. all retest 3 months later. (at 16 weeks or 20 weeks) ]Measures 5 dimensions of fatigue: general, physical, mental, reduced motivation and reduced activity. Scores 4-20 in each dimension. The hypothesis to be tested is that scores will decrease after the intervention compared to waitlist controls and that they will remain stable at 3 month follow up.
- Short-form McGill Pain Questionnaire revised (SF-MPQ-2) [ Time Frame: all Subjects will be tested at baseline, at week 5 after intervention or control wait period. control retest after intervention at week 10. all retest 3 months later. (at 16 weeks or 20 weeks) ]Measures sensory and affective perception of pain and total score is calculated from the mean of 22 items. Score 0-10 The hypothesis to be tested is that scores will decrease after the intervention compared to waitlist controls and that they will remain stable at 3 month follow up.
- 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 from neurocognitive test battery 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.
- 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.
- rates of recruitment, accrual and retention, feasibility [ Time Frame: during entire trial ]feasibility
- rates of any unanticipated adverse effects [ Time Frame: during intervention or waitlist period ]safety
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672710
|United States, Maryland|
|Severna Park Health and Wellness Center|
|Annapolis, Maryland, United States, 21401|
|Principal Investigator:||David O Carpenter, MD||University at Albany|