Gulf War Illness: Evaluation of an Innovative Detoxification Program

NCT01672710 | Completed Phase 2 Results

• 1 other identifier: GW093066
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Gulf War Illness

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, 5 weeks

Secondary Outcomes (1)

• Fatigue Severity

  baseline, 5 weeks

Study Arms (2)

regimen of niacin, exercise, sauna,

EXPERIMENTAL

4-5 week daily sauna, exercise and niacin with other supplements

Drug: plain crystalline niacin, exercise, sauna

waitlist

OTHER

4 week waitlist with treatment as usual

Drug: plain crystalline niacin, exercise, sauna

Interventions

plain crystalline niacin, exercise, sauna DRUG

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.

Also known as: Hubbard detoxification program

regimen of niacin, exercise, sauna,; waitlist

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Any veteran of the 1990-1991 Gulf War who meets the Kansas Gulf War Illness case definition.

Sponsors & Collaborators

• University at Albany: lead
• United States Department of Defense: collaborator
• The Sage Colleges: collaborator
• Women's College Hospital: collaborator
• Severna Park Health and Wellness Center: collaborator

Study Sites (1)

Severna Park Health and Wellness Center

Annapolis, Maryland, 21401, United States

Location

Related Publications (1)

• 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.

  PMID: 33499551 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Steam Bath

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Balneology; Therapeutics; Hyperthermia, Induced

Results Point of Contact

• Title: David O. Carpenter MD
• Organization: Institute for Health and the Environment, University at Albany

dcarpenter@albany.edu

518-525-2660

Study Officials

• David O Carpenter, MD

  University at Albany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Institute for Health and the Environment, University at Albany

Model Details: Pilot

Study Record Dates

• First Submitted: August 15, 2012
• First Posted: August 27, 2012
• Study Start: April 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 13, 2020
• Results First Posted: December 28, 2018

Record last verified: 2020-04

Locations

US (1)