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
Results First Posted : December 28, 2018
Last Update Posted : April 13, 2020
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Tracking Information | ||||
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First Submitted Date ICMJE | August 15, 2012 | |||
First Posted Date ICMJE | August 27, 2012 | |||
Results First Submitted Date ICMJE | July 31, 2018 | |||
Results First Posted Date ICMJE | December 28, 2018 | |||
Last Update Posted Date | April 13, 2020 | |||
Study Start Date ICMJE | April 2010 | |||
Actual Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE |
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.
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures |
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.
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Descriptive Information | ||||
Brief Title ICMJE | Gulf War Illness: Evaluation of an Innovative Detoxification Program | |||
Official Title ICMJE | 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:
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Pilot Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Gulf War Illness | |||
Intervention ICMJE | 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
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Study Arms ICMJE |
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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. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
32 | |||
Original Estimated Enrollment ICMJE |
50 | |||
Actual Study Completion Date ICMJE | December 2015 | |||
Actual Primary Completion Date | August 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01672710 | |||
Other Study ID Numbers ICMJE | GW093066 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE |
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Current Responsible Party | David O. Carpenter, University at Albany | |||
Original Responsible Party | Same as current | |||
Current Study Sponsor ICMJE | University at Albany | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University at Albany | |||
Verification Date | April 2020 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |