Gulf War Illness
Conditions
Keywords
Hubbard detoxification, Exercise, Sauna therapy, Niacin, 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.
Interventions
DRUGplain 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.
Sponsors
United States Department of Defense
The Sage Colleges
Women's College Hospital
Severna Park Health and Wellness Center
University at Albany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form-36 for Veterans Quality of Life Physical Component Summary Scores | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Niacin, Exercise, Sauna, 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. | 22 |
| no Intervention treatment as usual for 4 weeks | 10 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3 Month Follow up | follow up due after termination date | 4 | 1 |
| 3 Month Follow up | Lost to Follow-up | 2 | 3 |
| Waitlist Assessed After Sauna Regimen | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Niacin, Exercise, Sauna, | no Intervention | Total |
|---|---|---|---|
| Age, Continuous | 51.7 years STANDARD_DEVIATION 7.9 | 50.2 years STANDARD_DEVIATION 5.5 | 51.2 years STANDARD_DEVIATION 7.2 |
| Sex: Female, Male Female | 7 Participants | 3 Participants | 10 Participants |
| Sex: Female, Male Male | 15 Participants | 7 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 10 |
| other Total, other adverse events | 3 / 22 | 0 / 10 |
| serious Total, serious adverse events | 0 / 22 | 0 / 10 |
Outcome results
Primary
Short Form-36 for Veterans Quality of Life Physical Component Summary Scores
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.
Time frame: baseline, 5 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin, Exercise, Sauna, | Short Form-36 for Veterans Quality of Life Physical Component Summary Scores | baseline PCS score | 30.3 score on a scale | Standard Deviation 8.9 |
| Niacin, Exercise, Sauna, | Short Form-36 for Veterans Quality of Life Physical Component Summary Scores | 5 week PCS scores | 38.2 score on a scale | Standard Deviation 10.3 |
| no Intervention | Short Form-36 for Veterans Quality of Life Physical Component Summary Scores | baseline PCS score | 36.7 score on a scale | Standard Deviation 10.5 |
| no Intervention | Short Form-36 for Veterans Quality of Life Physical Component Summary Scores | 5 week PCS scores | 35.7 score on a scale | Standard Deviation 12.1 |
p-value: <0.0595% CI: [-0.3, 14.2]ANCOVA
Secondary
Fatigue Severity
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.
Time frame: baseline, 5 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Niacin, Exercise, Sauna, | Fatigue Severity | Baseline fatigue score | 17.4 score on a scale | Standard Deviation 2.6 |
| Niacin, Exercise, Sauna, | Fatigue Severity | 5 week fatigue score | 12.8 score on a scale | Standard Deviation 4.8 |
| no Intervention | Fatigue Severity | Baseline fatigue score | 15.3 score on a scale | Standard Deviation 5.3 |
| no Intervention | Fatigue Severity | 5 week fatigue score | 15.7 score on a scale | Standard Deviation 3.6 |