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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
192
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.
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.
UC San Diego
La Jolla, California, United States
RECRUITINGNumber of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. on placebo.
All outcomes are assessed as change from baseline.
Time frame: 3.5 months
Percent improved on timed chair rises from Gulf War Illness Modified Lower Extremity Summary Performance Score.
All outcomes are assessed as change from baseline.
Time frame: 3.5 months
Mean change in single-item General Self-Rated Health (GSRH).
All outcomes are assessed as change from baseline. 5 point scale, higher is good.
Time frame: 3.5 months
Individual GWI Symptoms
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.
Time frame: 3.5, 7 months
Relation of change in time to do five chair rises to change in blood level of coenzyme Q10
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).
Time frame: 3.5, 7 months
Effect of CoQ10 in the majority male subset on symptoms.
Change in symptoms on coQ10 versus placebo will be assessed in men (male subset of sample).
Time frame: 3.5, 7 months
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Each participant receives one softgel three times a day. Arm 2 receives three 100mg 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.
Effect of CoQ10 in the majority male subset on timed chair rises.
Change in timed chair rises on coQ10 versus placebo will be assessed in men (male subset of sample).
Time frame: 3.5, 7 months
Effect of CoQ10 in the majority male subset on GSRH.
Change in GSRH on coQ10 versus placebo will be assessed in men (male subset of sample).
Time frame: 3.5, 7 months