Ca-Mg Butyrate for Gulf War Syndrome (Butyrate Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: VA Office of Research and Development
Prior Safety Data
Trial Summary
What is the purpose of 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.
Is Ca-Mg Butyrate a promising drug for Gulf War Syndrome?The research articles provided do not directly address the effectiveness of Ca-Mg Butyrate for Gulf War Syndrome. They discuss magnesium's role in other conditions, like asthma and blood pressure, but not specifically for Gulf War Syndrome. Therefore, based on the available information, we cannot conclude that Ca-Mg Butyrate is a promising drug for this condition.34679
Do I have to stop taking my current medications for the trial?Yes, you may need to stop certain medications. You cannot take medications that impact gut motility, diarrhea, chronic pain, immune function, or contain calcium or magnesium butyrate for at least 3 months before the study. Antibiotics and drugs affecting immune function should not be used in the past 1-2 months.
What safety data exists for Ca-Mg Butyrate treatment?The provided research does not directly address the safety data for Ca-Mg Butyrate or its derivatives. However, it includes studies on magnesium salts in different contexts, such as magnesium pidolate and magnesium sulfate, which were generally well tolerated with no adverse effects reported. This suggests that magnesium salts, in general, may have a favorable safety profile, but specific safety data for Ca-Mg Butyrate is not available in the provided research.1281012
What data supports the idea that Ca-Mg Butyrate for Gulf War Syndrome is an effective treatment?The available research does not provide any data supporting the effectiveness of Ca-Mg Butyrate for Gulf War Syndrome. The studies mentioned focus on magnesium treatments for asthma and allergic rhinitis, but they do not address Gulf War Syndrome or the specific use of Ca-Mg Butyrate. Therefore, there is no evidence from the provided information to suggest that Ca-Mg Butyrate is an effective treatment for Gulf War Syndrome.125711
Eligibility Criteria
This trial is for Gulf War era veterans aged between 40 and 70 who suffer from moderate to severe GWI, as defined by CDC and Kansas criteria. Participants must score less than 30 on the VSF36 physical domain, with no other health conditions that could explain their symptoms.Exclusion Criteria
I have a diagnosed inflammatory disorder.
I haven't taken immunosuppressive drugs or biologics in the last 3 months.
I have bipolar disorder and have not received treatment for it.
My organs are functioning properly.
I have had an organ transplant.
I haven't taken medications affecting my gut, pain, or immune system in the last 3 months.
I have schizophrenia that has not been treated.
Participant Groups
The trial tests if Ca-Mg Butyrate improves physical function in those with GWI. It measures changes in physical functioning via the VSF-36 survey and examines effects on gut microbiome, gastrointestinal issues, chronic fatigue, inflammation, and cognitive deficits.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Cal-Mag-ButyrateExperimental Treatment1 Intervention
Take oral capsule as directed (600 mg, twice a day for 18 weeks) with or without food.
Group II: Placebo for Cal-Mag-ButyratePlacebo Group1 Intervention
Take oral capsule as directed (600 mg, twice a day for 18 weeks) with or without food.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Wm. Jennings Bryan Dorn VA Medical Center, Columbia, SCColumbia, SC
VA Salt Lake City Health Care System, Salt Lake City, UTSalt Lake City, UT
VA Long Beach Healthcare System, Long Beach, CALong Beach, CA
Miami VA Healthcare System, Miami, FLMiami, FL
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
Miami VA Healthcare SystemCollaborator
VA Salt Lake City Health Care SystemCollaborator
References
Magnesium pidolate in the treatment of seasonal allergic rhinitis. Preliminary data. [2016]This paper describes how the authors, after examining the calcium modulating action of the Mg ion and its antihistamine-like action, tested a salt containing Mg (Mg pidolate, MAG2) in the clinical treatment of seasonal allergic rhinitis. A total of 38 hayfever subjects were studied. They were given 1.5 g Mg salt three times a day for one month (oral MAG2 vials); placebo was used as a control in a randomized double-blind study. The efficacy of the product was assessed using the following criteria: intensity of rhinorrhoea, daily consumption of Kleenex tissues, number of sneezes in a day, intensity of lacrimation. The results were analysed using Student's t test and demonstrated the clinical efficacy of the product in the control of seasonal allergic rhinitis symptoms (P less than 0.001).
Effect of an inhaled mast cell stabiliser, N-acetyl-aspartyl-glutamate (Zy15109) on allergen-induced immediate bronchoconstriction. [2019]We have studied the effect of a mast cell stabiliser, the magnesium salt of N-acetyl aspartyl glutamic acid (NAAGA) on allergen-induced immediate bronchoconstriction in 12 atopic subjects. Inhaled NAAGA, at a dose of 60 mg thrice daily for 1 week, offered no protective effect on the airways against allergen challenge when compared with a matched placebo. The drug was well tolerated with no adverse effects observed.
Lack of effect of oral magnesium on high blood pressure: a double blind study. [2019]Seventeen unselected patients with mild to moderate essential hypertension and whose average supine blood pressure after two months' observation with no treatment was 154/100 mm Hg were entered into a double blind randomised crossover study of one month's treatment with magnesium aspartate (15 mmol magnesium/day) and treatment with placebo for a further month. This preparation of magnesium was well tolerated and did not cause diarrhoea. Despite a significant increase in plasma magnesium concentration and a significant increase in urinary excretion of magnesium while taking magnesium aspartate there was no fall in blood pressure compared with either treatment with placebo or values before treatment. The results provide no evidence for a role of dietary magnesium in the regulation of high blood pressure and are contrary to recent speculations.
Quinolinate and kainate facilitate magnesium penetration into brain tissue. [2019]To study the penetration of magnesium ions from blood into brain tissue, magnesium content in serum and hippocampus of normal and of excitotoxically affected rats was estimated after a single subcutaneous injection of magnesium sulphate (600 mg kg-1). In normal rats Mg2+ levels in serum rose from 1 to 6 mM, while that of the hippocampus remained constant, provided the brains were perfused before magnesium measurement. Following unilateral intracerebroventricular injection of the excitotoxic glutamate analogues, quinolinate or kainate acid, Mg2+ levels increased up to 38% on the (unaffected) contralateral side. Since magnesium is known to prevent glutamate-mediated neurodegeneration, our findings on the accessibility of exogenously applied magnesium may justify further investigations on the utility of magnesium for a therapeutic approach to limiting excitotoxic brain injury in human patients.
Investigation of the effect of short-term change in dietary magnesium intake in asthma. [2019]Epidemiological evidence suggests that a low dietary intake of magnesium is associated with impaired lung function, bronchial hyperreactivity and wheezing. This study was designed to investigate whether short-term alterations of dietary magnesium intake have an effect on the clinical control of asthma. In a randomized, double-blind, placebo-controlled, cross-over study, 17 asthmatic subjects adhered to a low magnesium diet for two periods of 3 weeks, preceded and separated by a 1 week run-in/wash-out, in which they took either placebo or magnesium (400 mg x day(-1)) tablet supplementation. Forced expiratory volume in one second (FEV1) and the provocative dose of methacholine required to cause a 20% fall in FEV1 from baseline (PD20,FEV1) were measured at the beginning and end of each treatment period, and variation in peak expiratory flow (PEF) rate, bronchodilator use and symptom scores recorded throughout. Asthma symptom scores were significantly lower during the magnesium treatment period, the median (95% confidence interval) difference from placebo being 3.8 (0.5-7.0) symptom points per 7 days (p=0.02). However, there was no significant improvement in FEV1, PD20,FEV1, log amplitude percentage mean PEF variation or bronchodilator use during magnesium supplementation. A high magnesium intake was associated with improvement in symptom scores, though not in objective measures of airflow or airway reactivity, in these stable asthmatic subjects.
Mg citrate found more bioavailable than other Mg preparations in a randomised, double-blind study. [2022]Published data on the bioavailability of various Mg preparations is too fragmented and scanty to inform proper choice of Mg preparation for clinical studies. In this study, the relative bioavailability of three preparations of Mg (amino-acid chelate, citrate and oxide) were compared at a daily dose of 300 mg of elemental Mg in 46 healthy individuals. The study was a randomised, double-blind, placebo-controlled, parallel intervention, of 60 days duration. Urine, blood and saliva samples were taken at baseline, 24 h after the first Mg supplement was taken ('acute' supplementation) and after 60 days of daily Mg consumption ('chronic' supplementation). Results showed that supplementation of the organic forms of Mg (citrate and amino-acid chelate) showed greater absorption (P = 0.033) at 60 days than MgO, as assessed by the 24-h urinary Mg excretion. Mg citrate led to the greatest mean serum Mg concentration compared with other treatments following both acute (P = 0.026) and chronic (P = 0.006) supplementation. Furthermore, although mean erythrocyte Mg concentration showed no differences among groups, chronic Mg citrate supplementation resulted in the greatest (P = 0.027) mean salivary Mg concentration compared with all other treatments. Mg oxide supplementation resulted in no differences compared to placebo. We conclude that a daily supplementation with Mg citrate shows superior bioavailability after 60 days of treatment when compared with other treatments studied.
Ionized magnesium levels and the ratio of ionized calcium to magnesium in asthma patients before and after treatment with magnesium. [2013]Prior studies have been equivocal about the efficacy of magnesium therapy in acute asthma exacerbations. We hypothesize that pretreatment ionized magnesium (Mg(2+)) levels and/or the ratio of ionized calcium to ionized magnesium (Ca(2+)/Mg(2+)) may have been confounding variables in these previous studies. Here, we report on the incidence of abnormal divalent ion levels in our asthma population.
Intravenous and nebulised magnesium sulphate for acute asthma: systematic review and meta-analysis. [2021]To estimate the effect of intravenous and nebulised magnesium sulphate upon hospital admissions and pulmonary function in adults and children with acute asthma.
Magnesium for treatment of asthma in children. [2021]Magnesium is considered adjuvant therapy for moderate to severe asthma exacerbations in adults, but can it be used to treat children?
Limitations of the results from randomized clinical trials involving intravenous and nebulised magnesium sulphate in adults with severe acute asthma. [2019]The role of intravenous (IV) or nebulised magnesium sulphate (MgSO4) in the treatment of severe acute asthma in adults is unclear. A controversy exists regarding its efficacy. In children MgSO4 has a more evident clinical effect, but the child population has not been considered in this work. The applicability of the results from randomized clinical trials (RCTs) involving MgSO4 in adult population is questioned in the optimal treatment of asthma exacerbations. According to the newest guidelines from the Global Initiative for Asthma (GINA), optimal treatment in the emergency department (ED) is based on short-acting beta2-agonists (SABA), oral or IV corticosteroids (CS), short acting muscarinic antagonists (SAMA) and the controlled oxygen therapy. Further improvements with IV or nebulised MgSO4 were assessed in a recent large multicentre, double-blind, placebo-controlled randomized 3 Mg trial, which failed to demonstrate clinical benefit. Several other RCTs found some benefit with MgSO4, although the majority lacked some treatment options that are used in the optimal treatment of asthma exacerbations. Therefore, we reviewed the limitations of RCTs of IV or nebulised MgSO4 in adults with acute asthma, with the aim to answer in which subpopulation MgSO4 could be beneficial.
The role of oral magnesium supplements for the management of stable bronchial asthma: a systematic review and meta-analysis. [2020]Asthma is a chronic lung disease characterized by airway inflammation and hyper-responsiveness of airway smooth muscles. There is growing evidence that magnesium may have a role in managing asthma through its dual effect as an anti-inflammatory and bronchodilating agent. To assess the efficacy of oral magnesium supplements in chronic asthmatic patients. In addition to searching through Clinicaltrials.gov/ and references for oral magnesium supplement studies, we performed a database search in Medline, CINAHL, CENTRAL, and Embase. We contacted the authors of the included trials to ask for additional information. We included randomized controlled trials that compared oral magnesium supplements versus placebo, in addition to standard asthma treatment in mild-moderate asthmatic adults and children (older than 6 years). Two reviewers independently performed the study selection, data abstraction, and the assessment of the risk of bias. Eight trials at moderate risk of bias enrolling a total of 917 patients were included. Oral magnesium improved FEV1 at week 8 (5.69 (L/min); 95% CI: 1.92, 9.46; I2: 45%). There was no significant improvement in FEV1 at other follow up periods. There was no significant change in FVC, Methacholine challenge test, the frequency of bronchodilator use, or symptoms score. There were no data on mortality or quality of life. Oral magnesium supplements may lead to improvement in FEV1 that was only demonstrated at eight weeks; but no effect on any other outcome. Until future evidence emerges, oral magnesium cannot be recommended as adjuvants to standard treatment for mild to moderate asthmatic individuals.
Magnesium sulfate treatment for acute severe asthma in adults-a systematic review and meta-analysis. [2023]Add-on magnesium sulfate (MgSO4) for refractory asthma exacerbation has been much debated. The aim of this review and meta-analysis is, therefore, to provide an update on the current evidence for the efficacy of MgSO4 in exacerbations of asthma in adults refractory to standard of care treatment.