Ca-Mg Butyrate in GWI

ConditionsGulf War Illness Chronic Fatigue Neurocognitive Dysfunction

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age40-70

SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gulf war era veteran deployed 40 and 70 years old, in good health by medical history prior to 1990 meeting GWI case definition of CDC and Kansas criteria and

currently have no exclusionary diagnoses (self- reported) that could reasonably explain the symptoms of their fatiguing illness. The severity of illness is moderate to severe, scoring less than 30 of 100 on the physical domain of VSF36 .

Disqualifiers

Untreated schizophrenia,

Untreated bipolar disorder,

Untreated delusional disorders,

Untreated dementias of any type and

Trial design

Design model

Parallel

Treatments tested in this trial

Cal-Mag Butyrate
Drug
Supplements
Placebo
Drug
Only Cal-Mag but no Butyric acid

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Cal-Mag-ButyrateExperimental treatment 1 intervention

Group B: Placebo for Cal-Mag-ButyratePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Veterans Short Form 36-Item Health Survey Physical Component Summary

Veterans Health Survey contains 36 items to measure health functioning from the patient's point of view. Qualify of life will be determined per Short Form-36 for Veterans' quality of life Physical component (PCS) summary scales, range from 0 to 100 with 100 being better; 50 is expected population average.

Time frame

Change from Baseline at 3, 6, 9, 12, 18 and 20 weeks

Secondary outcomes

California Verbal Learning Test (CVLT-II)

CVLT-II asks questions about cognitive symptoms related to recall and memory. The CVLT-II is used to measure verbal learning and episodic long-term memory. It assesses learning, short- and long-delayed recall and recognition for a list of 16 shopping items. Subjects are expected to remember a list of words. They are asked to repeat the words remembered 5 times (5 trials). Each of the words correctly remembered, in each trial, is marked as 1 point. The reported data represent the number of correct items for the Trial 1-Trial 5, Short Delay Free Recall, and Long Delay Free Recall. The long-delayed recall is assessed at 20 minutes. The CVLT enables a comprehensive characterization of a participant's memory profile. Scale ranges from 0 to 80 with 80 being the best.

Time frame

Change from Baseline at 9, 18 and 20 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Miami VA Healthcare System

Collaborator

VA Salt Lake City Health Care System