Coenzyme Q10 for Gulf War Illness: A Replication Study

ConditionsGulf War Syndrome Persian Gulf Syndrome Mitochondrial Disorder, Respiratory Chain

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age50+

SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

PharmaNord Bio-Quinone Active CoQ10 Gold 100mg
Drug
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.
PharmaNord Placebo
Drug
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.
PharmaNord Bio-Quinone Active CoQ10 Gold 100mg
Drug
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.

Treatment groups

192 Participants

are divided into 3 treatment groups

Group A: CoQ10 Arm 1Active comparator 1 intervention

Group B: CoQ10 Arm 2Active comparator 1 intervention

Group C: Placebo ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

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.

All outcomes are assessed as change from baseline.

Time frame

3.5 months

Secondary outcomes

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

Other outcomes

The investigator will assess whether there is a difference in change effect for the 100mg/day vs 300mg/day arm on symptoms.

Compare the effect of coQ10 300mg/day to placebo, and to coQ10 100mg/d on symptoms.

Time frame

3.5, 7 months

The investigator will assess whether there is a difference in change effect for the 100mg/day vs 300mg/day arm on timed chair rises.

Compare the effect of coQ10 300mg/day to placebo, and to coQ10 100mg/d on timed chair rises.

Time frame

3.5, 7 months

The investigator will assess whether there is a difference in change effect for the 100mg/day vs 300mg/day arm on GSRH.

Compare the effect of coQ10 300mg/day to placebo, and to coQ10 100mg/d on GSRH.

Time frame

3.5, 7 months

Duration Effect on symptoms. Compare effects of 7 months vs 3.5 months of treatment, assessed at the same time point after baseline (7 months) on symptoms.

Following seven months of study participation, participants will have been on coQ10 for either 3.5 months or 7 months. These two groups will be compared to assess the impact of longer vs. shorter duration treatment (those initially randomized to placebo will crossover to active coQ10 for the final 3.5 months, while those originally randomized to coQ10 will have been on coQ10 for 7 months).

Time frame

7 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

United States Department of Defense

Collaborator

Source ClinicalTrials.gov

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