Mitochondrial Cocktail for Gulf War Illness

Gulf War Syndrome Clinical Trial

Official title:

Beyond Benefits of Q10: Mitochondrial Cocktail for Gulf War Illness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804828
• Other study ID #: GW140146
• Status: Completed
• Phase: N/A
• Start date: April 9, 2021
• Est. completion date: April 3, 2023

Study information

• Verified date: April 2023
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop preliminary evidence, such as effect size and variance estimates, to guide successful conduct of a properly-powered clinical trial to assess the benefit of a mitochondrial cocktail (incorporating individualization of treatment) in Gulf War illness (GWI).

Description:

See below.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 3, 2023
• Est. primary completion date: April 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Years and older

Eligibility

Inclusion Criteria:

• Meet symptom criteria for Gulf War illness with BOTH the Centers for Disease Control and Prevention (CDC) Criteria (persistent symptoms in at least 2 of 3 designated symptom domains of fatigue/sleep, mood/cognition, and musculoskeletal) and Kansas Criteria (score a moderate or severe rating in at least 3 of the 6 symptom domains of fatigue, pain, neurological/cognitive/mood, skin, GI and respiratory).

Exclusion Criteria:

• Have conditions like multiple sclerosis or lupus that can produce similar symptoms and be confused for Gulf War illness.

• Participating in a concurrent treatment trial.

• Unwilling or unable to comply with the treatment protocol

• Failed run-in; do not take at least 80% of run-in medications

Related Conditions & MeSH terms

• Gulf War Syndrome
• Mitochondrial Diseases
• Mitochondrial Disorders
• Persian Gulf Syndrome
• Syndrome

Intervention

Dietary Supplement:
• Individualized mitochondrial cocktail
Nutrient cocktail comprising: thiamine, nicotinamide, pantothenic acid, riboflavin, L-carnitine, alpha lipoic acid, CoQ10, vitamin C, vitamin E, and omega 3 fatty acids (Cod Liver Oil).
• Placebo
6 months for the double-blind phase

Locations

Country	Name	City	State
United States	UC San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in single item General Self-Rated Health Visual Analog Scale from baseline		0, 3, 6 months (double-blind phase)
Primary	Percent improved on Gulf War Illness Modified Lower Extremity Performance Score/timed chair rises		6 months (double-blind phase)
Primary	Number of symptoms (out of 20 on the UCSD Symptom Score Survey) showing more favorable change (trend or effect) on active treatment vs. placebo		0, 3, 6 months (double-blind phase)
Primary	Mean change of CoQ10 and Vitamin E levels, comparing active treatment to placebo		6 months (double-blind phase)
Secondary	Assessment of summed symptom score (sum of ratings for UCSD GWI symptom index)	Secondary measures will incorporate assessment of summed symptom score (sum of ratings for UCSD GWI symptom index) at primary endpoint time point. We will assess at additional time points (9, 12 month) and will assess effects stratified by sex; by dominant ethnicity; and by use of medications that can affect levels or disposition of supplement components (e.g. statin use).	6, 9, 12 months