Gulf War SyndromePhase 3NCT06515184
Coenzyme Q10 for Gulf War Illness: A Replication Study
A Phase 3 study testing PharmaNord Bio-Quinone Active CoQ10 Gold 100mg in people with Gulf War Syndrome and Persian Gulf Syndrome, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Gulf War Syndrome, Persian Gulf Syndrome, Mitochondrial Disorder, Respiratory Chain
- What is being tested?
- PharmaNord Bio-Quinone Active CoQ10 Gold 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2024to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC San Diego
La Jolla, California, 92093
Janis B. Ritchie, BSN, 858-558-4950 ext. 203, golombresearch@ucsd.edu
Beatrice A. Golomb, MD, PhD
About this study
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.
- Being tested
- PharmaNord Bio-Quinone Active CoQ10 Gold 100mg, PharmaNord Placebo
- Medical subject headings
- Persian Gulf Syndrome, Mitochondrial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PharmaNord Bio-Quinone Active CoQ10 Gold 100mgDrug
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 PlaceboDrug
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 100mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| CoQ10 Arm 1 | Active comparator | PharmaNord Ubiquinone 100mg/1x day Receives: Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg |
| CoQ10 Arm 2 | Active comparator | PharmaNord Ubiquinone 100mg/3x day Receives: Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mg |
| Placebo Arm | Placebo comparator | Placebo (made by PharmaNord, matches active treatment) Receives: Drug: PharmaNord Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3.5 months
Secondary outcomes (7)
Percent improved on timed chair rises from Gulf War Illness Modified Lower Extremity Summary Performance Score.
All outcomes are assessed as change from baseline.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 3.5, 7 months
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).
Measured: 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).
Measured: 3.5, 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start13 Sep 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Design (primary) is followed by active treatment phase (still blind to dose).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Beatrice Golomb, University of California, San Diego
- Investigators
- Beatrice A Golomb, MD, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515184
- Sponsor's protocol ID
- GW190064
- Status last verified
- Apr 2026
- First submitted
- 10 Jun 2024
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coenzyme Q10 for Gulf War Illness: A Replication Study
- ClinicalTrials.gov ID
- NCT06515184
- Acronym / sponsor ID
- GW190064
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Design (primary) is followed by active treatment phase (still blind to dose).
| Arm | Type | Receives |
|---|---|---|
| CoQ10 Arm 1 | Active comparator | Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mgPharmaNord Ubiquinone 100mg/1x day |
| CoQ10 Arm 2 | Active comparator | Drug: PharmaNord Bio-Quinone Active CoQ10 Gold 100mgPharmaNord Ubiquinone 100mg/3x day |
| Placebo Arm | Placebo comparator | Drug: PharmaNord PlaceboPlacebo (made by PharmaNord, matches active treatment) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PharmaNord Bio-Quinone Active CoQ10 Gold 100mgEach 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. | Drug | CoQ10 Arm 1 |
| PharmaNord PlaceboEach 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. | Drug | Placebo Arm |
| PharmaNord Bio-Quinone Active CoQ10 Gold 100mgEach 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. | Drug | CoQ10 Arm 2 |
Primary outcome
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.
Time frame: 3.5 months
All outcomes are assessed as change from baseline.
7 secondary outcomes
Percent improved on timed chair rises from Gulf War Illness Modified Lower Extremity Summary Performance Score.
Time frame: 3.5 months
Mean change in single-item General Self-Rated Health (GSRH).
Time frame: 3.5 months
Individual GWI Symptoms
Time frame: 3.5, 7 months
Relation of change in time to do five chair rises to change in blood level of coenzyme Q10
Time frame: 3.5, 7 months
Effect of CoQ10 in the majority male subset on symptoms.
Time frame: 3.5, 7 months
Effect of CoQ10 in the majority male subset on timed chair rises.
Time frame: 3.5, 7 months
Effect of CoQ10 in the majority male subset on GSRH.
Time frame: 3.5, 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
Related trials for Gulf War Syndrome
Not yet recruiting
Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness
Gulf War Syndrome
RecruitingPhase 1
Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
Gulf War Syndrome
Recruiting
Mechanisms of Gulf War Illness
Gulf War Illness, Irritable Bowel Syndrome
RecruitingPhase 2
Growth Hormone Replacement in Veterans With GWI and AGHD (GWIT)
Gulf War Syndrome, Adult Growth Hormone Deficiency
RecruitingPhase 2
Resistant Potato Starch to Alleviate GWI
Gulf War Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Beatrice A Golomb, MD, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing PharmaNord Bio-Quinone Active CoQ10 Gold 100mg in people with Gulf War Syndrome and Persian Gulf Syndrome, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janis B Ritchie, BSN (858-558-4950, jbritchie@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 3.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.