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NCT05367245 · ClinicalTrials.gov registry record · Phase 2
Ca-Mg Butyrate in GWI
A Phase 2 study of Gulf War Illness and Neurocognitive Dysfunction, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 3
- Study locations
NCT05367245 is a Phase 2 study of Gulf War Illness and Neurocognitive Dysfunction that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 120 participants, roughly in line with the 121-participant average among 14 other Gulf War Illness trials with a reported enrollment target. The trial reports 3 study locations across 3 states.
The verdict
NCT05367245, a Phase 2 study of Gulf War Illness and Neurocognitive Dysfunction, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cal-Mag Butyrate
Study Locations (3)
California
- VA Long Beach Healthcare System, Long Beach, CA - Long Beach
Florida
- Miami VA Healthcare System, Miami, FL - Miami
Utah
- VA Salt Lake City Health Care System, Salt Lake City, UT - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-01-15 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05367245
The ClinicalTrials.gov registry entry for NCT05367245 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 121-participant average among 14 other Gulf War Illness trials with a reported enrollment target. The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Gulf War Illness appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05367245 reports 3 study locations spanning 3 distinct geographic areas - top geographies include California, Florida, Utah.
Frequently Asked Questions
What is clinical trial NCT05367245 about?
NCT05367245 is a clinical study titled "Ca-Mg Butyrate in GWI". 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 ...
What is the current status of trial NCT05367245?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2024-01-15. Estimated completion is 2027-03-31.
What conditions does trial NCT05367245 study?
This clinical trial studies the following conditions: Gulf War Illness, Neurocognitive Dysfunction, Chronic Fatigue.
What interventions are being tested in trial NCT05367245?
The interventions under investigation include: Placebo (DRUG), Cal-Mag Butyrate (DRUG).
Who is sponsoring clinical trial NCT05367245?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05367245 being conducted?
This trial has 3 study locations across California, Florida, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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