Mitochondrial Cocktail for Gulf War Illness

NCT02804828 | Completed

• 1 other identifier: GW140146
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Gulf War Syndrome; Persian Gulf Syndrome; Mitochondrial Disorders

Outcome Measures

Primary Outcomes (4)

• Mean change in single item General Self-Rated Health Visual Analog Scale from baseline

  0, 3, 6 months (double-blind phase)

• Percent improved on Gulf War Illness Modified Lower Extremity Performance Score/timed chair rises

  6 months (double-blind phase)

• 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)

• Mean change of CoQ10 and Vitamin E levels, comparing active treatment to placebo

  6 months (double-blind phase)

Secondary Outcomes (1)

• Assessment of summed symptom score (sum of ratings for UCSD GWI symptom index)

  6, 9, 12 months

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Dietary Supplement: Individualized mitochondrial cocktail

Arm 2

SHAM COMPARATOR

Dietary Supplement: Placebo

Interventions

Individualized mitochondrial cocktail DIETARY_SUPPLEMENT

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).

Arm 1

Placebo DIETARY_SUPPLEMENT

6 months for the double-blind phase

Arm 2

Eligibility Criteria

• Age: 48 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Persian Gulf Syndrome; Mitochondrial Diseases

Condition Hierarchy (Ancestors)

Occupational Diseases; War-Related Injuries; Wounds and Injuries; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Parallel Design study is followed by Crossover to open label treatment.

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: June 17, 2016
• Study Start: April 9, 2021
• Primary Completion: April 3, 2023
• Study Completion: April 3, 2023
• Last Updated: April 5, 2023

Record last verified: 2023-04

Locations

US (1)