Ca-Mg Butyrate in GWI

Part of paid clinical trials in Long Beach, California.

Sponsor
VA Office of Research and Development
Study ID
NCT05367245
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Chronic Fatigue
  • Gulf War Illness
  • Neurocognitive Dysfunction

Eligibility Criteria

Sex
ALL
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Cal-Mag Butyrate — DRUG
    Supplements
  • Placebo — DRUG
    Only Cal-Mag but no Butyric acid

Study Details

The primary objective of this clinical trial is to determine if treatment with Butyrate formulation that consists of butyric acid as calcium and magnesium derivatives (Ca-Mg Butyrate) improves the physical function of men and women Veterans suffering from Gulf War Illness (GWI). The primary outcome measure is a change from baseline on the Short Form Health Survey 36-item (VSF-36), with respect to physical functioning and symptoms. The secondary outcome will focus on the drug's role in (a) restoring gut microbiome and virome, (b) decreasing gastrointestinal disturbances (constipation, diarrhea, pain), (c) decreasing chronic fatigue, (d) decreasing systemic inflammation, and (e) a decrease in cognitive deficits.

Key Dates

Start date
Jan 15, 2024
Status verified
Oct 2025
Primary completion
Oct 10, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cal-Mag-Butyrate
    Take oral capsule as directed (600 mg, twice a day for 18 weeks) with or without food.
  • Placebo Comparator: Placebo for Cal-Mag-Butyrate
    Take oral capsule as directed (600 mg, twice a day for 18 weeks) with or without food.

Primary Outcome Measure

Veterans Short Form 36-Item Health Survey Physical Component Summary [ Time Frame: Change from Baseline at 3, 6, 9, 12, 18 and 20 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
VA Long Beach Healthcare System, Long Beach, CALong BeachCalifornia90822
Saurabh Chatterjee, PhD
[email protected]
(562) 826-8000
Saurabh Chatterjee, PhD (PRINCIPAL_INVESTIGATOR)
Miami VA Healthcare System, Miami, FLMiamiFlorida33125
Nancy Klimas, MD
[email protected]
305-575-7000
Devra Cohen, MPH
[email protected]
3055757648
VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake CityUtah84148-0001
Ashok Tuteja, MD
[email protected]
801-582-1565

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VA Long Beach Healthcare System, Long Beach, CA· Long Beach, CAMiami VA Healthcare System, Miami, FL· Miami, FLVA Salt Lake City Health Care System, Salt Lake City, UT· Salt Lake City, UT

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