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RECRUITING Phase 2

Ca-Mg Butyrate in GWI

NCT05367245 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 120 participants
Start Date 2024-01-15
Est. Completion 2027-03-31
Phase Phase 2

Sponsor

VA Office of Research and Development

1,863 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05367245 reports 3 study locations spanning 3 distinct geographic areas — top geographies include California, Florida, Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05367245?

The interventions under investigation include: Placebo (DRUG), Cal-Mag Butyrate (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05367245?

This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial