Coenzyme Q10 for Gulf War Illness: A Replication Study

NCT ID: NCT06515184

Last Updated: 2024-11-20

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

192 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-13

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gulf War Syndrome Persian Gulf Syndrome Mitochondrial Disorder, Respiratory Chain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Design (primary) is followed by active treatment phase (still blind to dose).
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CoQ10 Arm 1

PharmaNord Ubiquinone 100mg/1x day

Group Type ACTIVE_COMPARATOR

PharmaNord Bio-Quinone Active CoQ10 Gold 100mg

Intervention Type 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.

CoQ10 Arm 2

PharmaNord Ubiquinone 100mg/3x day

Group Type ACTIVE_COMPARATOR

PharmaNord Bio-Quinone Active CoQ10 Gold 100mg

Intervention Type 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.

Placebo Arm

Placebo (made by PharmaNord, matches active treatment)

Group Type PLACEBO_COMPARATOR

PharmaNord Placebo

Intervention Type 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.

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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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United States Department of Defense

FED

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Beatrice Golomb

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Janis B Ritchie, BSN

Role: CONTACT

858-558-4950

Facility Contacts

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Janis B. Ritchie, BSN

Role: primary

858-558-4950 ext. 203

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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GW190064

Identifier Type: -

Identifier Source: org_study_id

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