CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 100 enrolled
Drug / intervention
Ubiquinol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02865460
NCT02865460Phase 3Completed

A Randomized, Double-blind Placebo-controlled Phase III Trial of Coenzyme Q10 in Gulf War Illness

VA Office of Research and Development·interventional·Posted Aug 12, 2016·Updated Feb 15, 2023

In Brief

A Phase 3 clinical trial evaluating Ubiquinol and Placebo for Gulf War Illness and 3 related conditions. Completed, enrolled 100 participants across 4 sites.

Detailed Summary

The primary objective of this clinical trial is to determine if treatment with ubiquinol, a form of coenzyme Q10, improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (SF-36), with respect to physical functioning and symptoms. Secondary outcome measures include changes from baseline levels on GWI-associated biomarkers in peripheral blood and GWI-associated symptoms of chronic pain, fatigue, insomnia, activity level, and cognitive and mental functioning.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 12, 2016
Enrollment StartJul 24, 2017
Primary CompletionOct 7, 2020
Study CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 9.9 years ago

Interventions

Ubiquinoldrug

Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking

Placebodrug

Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking