Mitochondrial Cocktail for Gulf War Illness

NCT ID: NCT02804828

Last Updated: 2023-04-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-09

Study Completion Date

2023-04-03

Brief Summary

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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).

Detailed Description

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See below.

Conditions

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Gulf War Syndrome Persian Gulf Syndrome Mitochondrial Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Design study is followed by Crossover to open label treatment.
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Arm 1

Group Type ACTIVE_COMPARATOR

Individualized mitochondrial cocktail

Intervention Type 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 2

Group Type SHAM_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

6 months for the double-blind phase

Interventions

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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).

Intervention Type DIETARY_SUPPLEMENT

Placebo

6 months for the double-blind phase

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

48 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Beatrice Golomb

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UC San Diego

La Jolla, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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GW140146

Identifier Type: -

Identifier Source: org_study_id

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