Cal-Mag Butyrate for Gulf War Illness

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Miami VA Healthcare System, Miami, FL, Miami, FL
Gulf War Illness+3 More
Cal-Mag Butyrate - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Gulf War Illness
  • Chronic Fatigue
  • Neurocognitive Dysfunction

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: Change from Baseline at 3, 6, 9, 12, 18 and 20 weeks

Week 20
Veterans Short Form 36-Item Health Survey Physical Component Summary
Week 20
California Verbal Learning Test (CVLT-II)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Cal-Mag-Butyrate
1 of 2
Placebo for Cal-Mag-Butyrate
1 of 2
Experimental Treatment
Non-Treatment Group

120 Total Participants · 2 Treatment Groups

Primary Treatment: Cal-Mag Butyrate · Has Placebo Group · Phase 2

Cal-Mag-Butyrate
Drug
Experimental Group · 1 Intervention: Cal-Mag Butyrate · Intervention Types: Drug
Placebo for Cal-Mag-Butyrate
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change from baseline at 3, 6, 9, 12, 18 and 20 weeks
Closest Location: Miami VA Healthcare System, Miami, FL · Miami, FL
Photo of Miami  1Photo of Miami  2Photo of Miami  3
2008First Recorded Clinical Trial
2 TrialsResearching Gulf War Illness
23 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a history of deployment to the Gulf War in 1990
You have no exclusionary diagnoses (self-reported) that could reasonably explain the symptoms of your fatiguing illness

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.