Gulf War IllnessPhase 2NCT01672710
Gulf War Illness: Evaluation of an Innovative Detoxification Program
A Phase 2 study testing plain crystalline niacin, exercise, sauna in people with Gulf War Illness, run by University at Albany at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- plain crystalline niacin, exercise, sauna
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any veteran of the 1990-1991 Gulf War who meets the Kansas Gulf War Illness case definition.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Severna Park Health and Wellness Center
Annapolis, Maryland, 21401
About this study
Official title: Pilot Study of Application of the Hubbard Detoxification Program to Veterans With Gulf War Illness
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.
Read the 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.
- Conditions
- Gulf War Illness
- Being tested
- plain crystalline niacin, exercise, sauna
- Keywords
- Hubbard detoxification, Exercise, Sauna therapy, Niacin, Gulf War illness
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plain crystalline niacin, exercise, saunaDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| regimen of niacin, exercise, sauna, | Experimental | 4-5 week daily sauna, exercise and niacin with other supplements Receives: Drug: plain crystalline niacin, exercise, sauna |
| waitlist | Other | 4 week waitlist with treatment as usual Receives: Drug: plain crystalline niacin, exercise, sauna |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 5 weeks
Secondary outcomes (1)
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.
Measured: baseline, 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startApr 2010
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University at Albany
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, The Sage Colleges, Women's College Hospital, Severna Park Health and Wellness Center
- Responsible party
- Principal investigator, David O. Carpenter, University at Albany
- Investigators
- David O Carpenter, MD, Principal investigator, University at Albany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672710
- Sponsor's protocol ID
- GW093066
- Status last verified
- Apr 2020
- First submitted
- 15 Aug 2012
- Last updated
- 13 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Graves DF, Morse GS, Kerr K, Carpenter DO. A Pilot Study to Examine Psychological and Neuropsychological Outcomes and a Novel Detoxification Program for Gulf War Illness. Mil Med. 2021 Jan 25;186(Suppl 1):205-213. doi: 10.1093/milmed/usaa486.
PubMed 33499551
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Application of the Hubbard Detoxification Program to Veterans With Gulf War Illness
- ClinicalTrials.gov ID
- NCT01672710
- Acronym / sponsor ID
- GW093066
- Conditions
- Gulf War Illness
- Keywords
- Hubbard detoxification, Exercise, Sauna therapy, Niacin, Gulf War illness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University at AlbanyUniversity, hospital or other
- Collaborators
- United States Department of Defense, The Sage Colleges, Women's College Hospital, Severna Park Health and Wellness Center
- Study start
- Apr 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Posted 28 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot
| Arm | Type | Receives |
|---|---|---|
| regimen of niacin, exercise, sauna, | Experimental | Drug: plain crystalline niacin, exercise, sauna4-5 week daily sauna, exercise and niacin with other supplements |
| waitlist | Other | Drug: plain crystalline niacin, exercise, sauna4 week waitlist with treatment as usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any veteran of the 1990-1991 Gulf War who meets the Kansas Gulf War Illness case definition.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plain crystalline niacin, exercise, saunaAlso: Hubbard detoxification programA 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. | Drug | regimen of niacin, exercise, sauna,, waitlist |
Primary outcome
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.
1 secondary outcome
Fatigue Severity
Time frame: baseline, 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33499551Graves DF, Morse GS, Kerr K, Carpenter DO. A Pilot Study to Examine Psychological and Neuropsychological Outcomes and a Novel Detoxification Program for Gulf War Illness. Mil Med. 2021 Jan 25;186(Suppl 1):205-213. doi: 10.1093/milmed/usaa486.
- Individual participant dataSharing planned: Undecided
Related trials for Gulf War Illness
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Mechanisms of Gulf War Illness
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David O Carpenter, MD principal investigator
University at Albany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing plain crystalline niacin, exercise, sauna in people with Gulf War Illness, run by University at Albany at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form-36 for Veterans Quality of Life Physical Component Summary Scores (time frame: baseline, 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01672710, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2020.