Gulf War Illness: Evaluation of an Innovative Detoxification Program

• ClinicalTrials.gov Identifier: NCT01672710
• Recruitment Status: Completed
• First Posted: August 27, 2012
• Results First Posted: December 28, 2018
• Last Update Posted: April 13, 2020
• Sponsor: University at Albany
• Collaborators: United States Department of Defense; The Sage Colleges; Women's College Hospital; Severna Park Health and Wellness Center
• Information provided by (Responsible Party): David O. Carpenter, University at Albany

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Gulf War Illness	Drug: plain crystalline niacin, exercise, sauna	Phase 2

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Pilot
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: regimen of niacin, exercise, sauna,; 4-5 week daily sauna, exercise and niacin with other supplements	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
waitlist; 4 week waitlist with treatment as usual	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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Maryland

Severna Park Health and Wellness Center

Annapolis, Maryland, United States, 21401

Sponsors and Collaborators

University at Albany

United States Department of Defense

The Sage Colleges

Women's College Hospital

Severna Park Health and Wellness Center

Investigators

• Principal Investigator: David O Carpenter, MD; University at Albany

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: David O. Carpenter, Director, Institute for Health and the Environment, University at Albany, University at Albany
• ClinicalTrials.gov Identifier: NCT01672710
• Other Study ID Numbers: GW093066
• First Posted: August 27, 2012
• Results First Posted: December 28, 2018
• Last Update Posted: April 13, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by David O. Carpenter, University at Albany:

Hubbard detoxification; Exercise; Sauna therapy; Niacin; Gulf War illness

Additional relevant MeSH terms:

Niacin; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Vasodilator Agents; Vitamin B Complex; Vitamins; Micronutrients; Physiological Effects of Drugs