|
Magnesium and Asthma - Clinical Trials Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about Magnesium and Asthma - Clinical Trials conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Magnesium and Asthma - Clinical Trials Clinical research trials and Magnesium and Asthma - Clinical Trials health trials occur in many of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including Magnesium and Asthma - Clinical Trials. Magnesium and Asthma - Clinical Trials Clinical Trials and other clinical trials permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Magnesium and Asthma - Clinical Trials clinical trial. Test subjects typically receive the most expert healthcare available for their Magnesium and Asthma - Clinical Trials condition. Dangers are a reality, however, and may include more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "M" Clinical Trials Conditions > Magnesium and Asthma - Clinical Trials  Magnesium and Asthma - Clinical Trials
Magnesium and Asthma - Clinical Trials
For Condition: Asthma
Status: Recruiting
Sponsor(s): National Center for Complementary and Alternative Medicine (NCCAM) ,
Synopsis: Asthma currently affects an estimated 15 million Americans. A number of studies have found an association between low dietary magnesium (Mg) intake and increased asthma incidence and severity of symptoms. However, clinical intervention trials are necessary to directly assess whether there is a true protective or preventative causal relationship between low Mg and asthma. In our study, we will assess the effects of 6 1/2 months of oral Mg supplements or placebo on clinical markers of asthma control, indirect biomarkers of inflammation, bronchial hyperresponsiveness, and indices of oxidative defense and damage in subjects with mild to moderate persistent asthma.
Details: Over the past twenty years a number of studies of acute bronchial asthma have shown that i.v. or nebulized MgS04 may improve symptoms over a course of hours. With respect to dietary supplementation, short term (3 wk) oral Mg has been associated with a significant decrease in symptoms but no significant effect on measurements like FEV1 or bronchial hyperreactivity by methacholine challenge. Although a large number of studies have attempted to address this issue, we believe that major gaps still exist. One of the gaps is in the comparison of large numbers of asthmatics and non-asthmatics, with regard to dietary intake, and a variety of measures of Mg status. We will evaluate baseline Mg intake (diet, tap and bottled drinking water, vitamin-mineral supplements, laxatives, and antacids), and multiple measures of Mg status, such as total and free serum Mg, total erythrocyte Mg, and Mg retention after an IV Mg load in subjects with and without asthma. Furthermore there are no large-scale studies evaluating the effects of Mg supplementation on asthma control and clinical markers, and markers of inflammation. We propose to assess the effects of 6 1/2 months of oral Mg on clinical markers of asthma control (asthma symptom diary, monthly spirometry, asthma quality of life questionnaire (QOL)), indirect biomarkers of inflammation (exhaled nitric oxide and serum eosinophil cationic protein) and bronchial hyperresponsiveness (methacholine challenge)in subjects with mild to moderate persistent asthma. Dietary Mg will be assessed using the 24 hr recall. Our hypotheses are that 1.) subjects with mild to moderate persistent asthma, as defined by National Institutes of Health National Asthma Education and Prevention Program (NIH NAEPP) clinical guidelines will have poorer Mg status than nonasthmatics, and 2.) that marginal Mg intake and status may modulate the severity of asthma. Thus, subjects with asthma who have marginal intake/status and thus relatively lower total and free plasma Mg, lower erythrocyte total Mg, and higher Mg retention will show improvement in the aforementioned clinical and indirect biomarkers. In contrast, Mg supplements will have little effect in subjects with highest intakes and Mg status. We do not anticipate that Mg supplementation will replace conventional treatment, but may complement and decrease the need for conventional medication.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 21 Years/55 Years
Genders: Both
Protocol Entry Criteria: - Mild to moderate persistant asthma (NAEPP 1997 revised guidelines) - Current use of inaled beta-2- agonists or steroid inhaler therapy only (No use of prednisone in past 3 months) - No use of products (i.e. antacids, laxatives, supplements) containing more than 50 mg Mg daily in the last 3 months - No current use of theophylline, leukotriene antagonists, or other systemic immunomodulating compounds - Nonsmoker - No concurrent pulmonary disease (pulmonary hypertension, cystic fibrosis, sarcoidosis, bronchiectasis, hypersensitivity pneumonitis, restrictive lung disease, abnormal DLCOva) - No concurrent medical diagnoses (alcoholism, coronary artery disease, diabetes, HIV infection, chronic hepatitis, uncontrolled hypertension, chronic renal failure or a psychiatric disorder that is judged to make full participation difficult) - Not pregnant or lactating.
Total Enrollment: 240
Location and Contact Information:
University of California at Davis School of Medicine, Ticon 1, Suite 100B, 2000 Stockton Blvd *Recruiting*
Sacramento, California, 95817
United States
Recruiting Judith Stern 530-752-6575
Additional Information:
Study ID Numbers: 1 R01 AT00652-02;
Study Start Date: May 2002
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029510
Other Asthma Studies:
1. Strong Heart Study
2. Ozone and Rhinovirus-Induced Disease in Asthmatics
3. Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma
4. Genetic Epidemiology of Asthma in Costa Rica
5. Honolulu Heart Program
Related Studies:
Other Asthma Clinical Trials
Other California Clinical Trials
Other Sacramento Clinical Trials
Magnesium and Asthma - Clinical Trials
|
|
|
|
|
|
|
|
