Gulf War Syndrome, Mitochondrial Disorder, Respiratory Chain, Persian Gulf Syndrome
Conditions
Brief summary
The purpose of this study is to assess whether a high quality preparation of ubiquinone (coenzyme Q10) benefits symptoms, function, and quality of life in veterans with Gulf War illness.
Interventions
DRUGPharmaNord Bio-Quinone Active CoQ10 Gold 100mg
Each participant receives one softgel three times a day. Arm 1 receives one 100mg softgel and two placebo softgels per day. Because of the presence of the IND, the dropdown menu does not allow us to choose dietary supplement. The option "drug" was chosen as the closest permissible option.
DRUGPharmaNord Placebo
Each participant receives one softgel three times a day. Arm 3 receives three placebo softgels per day. Supplement is taken orally in divided doses, with the last softgel not close to bedtime. Because of the presence of the IND, the dropdown menu does not allow us to choose dietary supplement. The option "drug" was chosen as the closest permissible option.
Sponsors
University of California, San Diego
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Parallel Design (primary) is followed by active treatment phase (still blind to dose).
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meets both CDC and Kansas deployment and symptom inclusion criteria. * Does not have a disqualifying condition. * Able to travel to a local Quest facility for study blood draws. * Adequate internet access to allow ZoomPro visit participation and remote survey completion. * Health prior to the Gulf War rated as "very good" or "excellent" (to exclude persons who may have had other health conditions with different mechanisms as the cause of their symptoms). * Willing to defer initiation of discretionary treatments or supplements during the expected course of study participation.
Exclusion criteria
* Participating in another clinical trial. * Still-evolving adverse effects following another medication or health condition, such as covid or fluoroquinolone use. * On Coumadin/ warfarin. * Unable to participate for the required duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. on placebo. | 3.5 months | All outcomes are assessed as change from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent improved on timed chair rises from Gulf War Illness Modified Lower Extremity Summary Performance Score. | 3.5 months | All outcomes are assessed as change from baseline. |
| Mean change in single-item General Self-Rated Health (GSRH). | 3.5 months | All outcomes are assessed as change from baseline. 5 point scale, higher is good. |
| Individual GWI Symptoms | 3.5, 7 months | 7 validated single-item symptom self-ratings: headache; energy; fatigue with exertion, muscle pain; irritability; impatience; trouble recalling words/names. Each benefited with coQ10, p\<0.05 (two-sided), in the prior coQ10 trial. |
| Relation of change in time to do five chair rises to change in blood level of coenzyme Q10 | 3.5, 7 months | Benefit to timed chair rises will relate to blood coQ10 change. This outcome assesses the relation between change in time to complete five chair rises (in seconds) to change in blood level of CoQ10 (in ug/mL). The prediction of change in time to perform five chair rises by change in coQ10 blood level (regression with robust standard errors). |
| Effect of CoQ10 in the majority male subset on symptoms. | 3.5, 7 months | Change in symptoms on coQ10 versus placebo will be assessed in men (male subset of sample). |
| Effect of CoQ10 in the majority male subset on timed chair rises. | 3.5, 7 months | Change in timed chair rises on coQ10 versus placebo will be assessed in men (male subset of sample). |
| Effect of CoQ10 in the majority male subset on GSRH. | 3.5, 7 months | Change in GSRH on coQ10 versus placebo will be assessed in men (male subset of sample). |
Countries
United States
Contacts
CONTACTJanis B Ritchie, BSN
PRINCIPAL_INVESTIGATORBeatrice A Golomb, MD, PhD
University of California, San Diego
Outcome results
None listed