Phase 2
N=32
Gulf War Illness: Evaluation of an Innovative Detoxification Program
Gulf War Illness
Bottom Line
View on ClinicalTrials.gov: NCT01672710 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Short Form-36 for Veterans Quality of Life Physical Component Summary Scores — 30.3; 36.7; 38.2; 35.7 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- plain crystalline niacin, exercise, sauna (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University at Albany
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Short Form-36 for Veterans Quality of Life Physical Component Summary Scores |
30.3; 36.7; 38.2; 35.7 | <0.05 sig |
| SECONDARY Fatigue Severity |
17.4; 15.3; 12.8; 15.7 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01672710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.