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Trial record 2 of 6 for:    Recruiting, Not yet recruiting, Available Studies | "Persian Gulf Syndrome"

Glutathione vs. Curcumin Clinical Trial (Glutathione)

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ClinicalTrials.gov Identifier: NCT02848417
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Nancy Klimas, South Florida Veterans Affairs Foundation for Research and Education

Brief Summary:
The investigator proposes to perform a phase I/II study comparing two nutraceuticals and placebo that target mediators identified in the investigator's prior dynamic modeling study of Gulf War Illness (GWI). The investigator will repeat the dynamic modeling before treatment and on therapy to assess the modeling and the impact of the interventions on the homeostatic networks that have identified, with an added focus on the glutathione/redox system.

Condition or disease Intervention/treatment Phase
Gulf War Syndrome Drug: Curcumin Drug: Glutathione Other: Placebo Phase 1 Phase 2

Detailed Description:
In the Investigator's prior study "Dynamic Modeling in GWI", the investigator used an exercise stress model (rest, peak oxygen consumption oxygen uptake, and 7 follow-up sampling points) to measure the mediators of relapse in the context of their interactive homeostatic networks. The investigator surveyed the response of genes and blood-borne biomarkers in order to interrogate and map regulation of neuro-endocrine-autonomic-immune function in these subjects as compared to GW era sedentary healthy controls. The investigator's research team applied an integrative systems-based approach rooted in computational biology connecting gene expression and biomarkers to pathways and to symptoms in order to identify potential therapeutic targets as well as optimal strategies for manipulation of these targets. Using this data the investigator's research team has developed a virtual model of the illness, which has been used to identify potential therapeutic targets.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Testing the Model: A Phase I/II Randomized Double Blind Placebo Control Trial of Targeted Therapeutics: Liposomal Glutathione and Curcumin
Study Start Date : April 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Curcumin
12 weeks 400mg orally twice a day
Drug: Curcumin
Perform a randomized phase I/II study comparing curcumin (increased bioavailable form, body cell mass-85, 400 mg twice a day) to glutathione (liposomal bioavailable form 630 mg bid), with a 3 month intervention and assessment of safety, efficacy and biomarker response to therapy.
Experimental: Liposomal Glutathione
12 weeks 630mg orally twice a day
Drug: Glutathione
Perform dynamic modeling studies before and after 3 months of therapy, repeating the method used previously in order to compare the response to exercise across groups and better quantify the degree of recovery in treated subjects using an exercise challenge and 9 point in time blood and saliva collections over 24 hours with genomic, cytokine, neuropeptide and cell population studies.
Experimental: Placebo Liquid or Capsules

Placebo liquid for Glutathione 120 ml per/ bottle 420 mg/5 ml

Placebo capsules for Curcumin 60 capsules per bottle 400 mg /cap

Other: Placebo

Placebo liquid 120 ml per/ bottle

Placebo capsules 60 capsules per bottle 400 mg /cap

With the addition of a Partner PI, redox/methylation expert Dr. Richard Deth, perform studies of antioxidant and methylation-related metabolic status prior to, during and after acute exercise in GWI subjects before and after interventions.




Primary Outcome Measures :
  1. Biomarker response to therapy using a VO2 exercise test [ Time Frame: 12 weeks ]
    Goal is that both will prove safe for use in GWI patients

  2. Biomarker response to therapy using cytokine panel [ Time Frame: 12 weeks ]
    Goal is that both will prove safe for use in GWI patients



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Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Veterans with Gulf War Illness
  • 35 to 70 years old
  • Good health by medical history prior to 1990
  • Currently have no exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity

Exclusion Criteria:

  • Major depression with psychotic or melancholic features
  • Schizophrenia
  • Bipolar disorder
  • Delusional disorders
  • Dementias of any type
  • History or current alcohol abuse
  • History or current drug abuse
  • Current tobacco use
  • Organ failure
  • Defined rheumatologic
  • Inflammatory disorders
  • HIV
  • Hepatitis B and C
  • Primary sleep disorders
  • Steroids
  • Immunosuppressives

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848417


Contacts
Contact: Fanny V Collado, RN 305-575-7000 ext 6706 fanny.collado@va.gov
Contact: Elizabeth Balbin 305-275-5450 ebalbin@med.miami.edu

Locations
United States, Florida
Miami VA Center Recruiting
Miami, Florida, United States, 33125
Contact: Nancy Klimas, MD    305-575-7000 ext 4800    Nacy.klimas@va.gov   
Contact: Fanny Collado, RN    305-575-7000 ext 6706    fanny.collado@va.gov   
Sponsors and Collaborators
South Florida Veterans Affairs Foundation for Research and Education
Investigators
Study Director: Elizabeth Balbin Nova University

Responsible Party: Nancy Klimas, M.D, South Florida Veterans Affairs Foundation for Research and Education
ClinicalTrials.gov Identifier: NCT02848417     History of Changes
Other Study ID Numbers: 4987
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Persian Gulf Syndrome
Occupational Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action