Mitochondrial Cocktail for Gulf War Illness

University of California San Diego

Status

Completed

Conditions

Persian Gulf Syndrome

Gulf War Syndrome

Mitochondrial Disorders

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Individualized mitochondrial cocktail

Study type

Interventional

Funder types

Other

Identifiers

NCT02804828

GW140146

Details and patient eligibility

About

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).

Full description

See below.

Enrollment

15 patients

Sex

All

Ages

48+ years old

Volunteers

No Healthy Volunteers

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