Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
192 participants
INTERVENTIONAL
2024-09-13
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CoQ10 Arm 1
PharmaNord Ubiquinone 100mg/1x day
PharmaNord 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.
CoQ10 Arm 2
PharmaNord Ubiquinone 100mg/3x day
PharmaNord Bio-Quinone Active CoQ10 Gold 100mg
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.
Placebo Arm
Placebo (made by PharmaNord, matches active treatment)
PharmaNord 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.
Interventions
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PharmaNord 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.
PharmaNord 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.
PharmaNord Bio-Quinone Active CoQ10 Gold 100mg
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
ALL
No
Sponsors
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United States Department of Defense
FED
University of California, San Diego
OTHER
Responsible Party
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Beatrice Golomb
Professor of Medicine
Principal Investigators
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Beatrice A Golomb, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Diego
Locations
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UC San Diego
La Jolla, California, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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GW190064
Identifier Type: -
Identifier Source: org_study_id
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