Magnesium and Asthma - Clinical Trials

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00029510
First received: January 14, 2002
Last updated: August 17, 2006
Last verified: July 2006
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Magnesium
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Magnesium and Asthma - Clinical Trials

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Estimated Enrollment: 240
Study Start Date: May 2002
Estimated Study Completion Date: June 2006
Detailed Description:

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

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • Mild to moderate persistent asthma (NAEPP 1997 revised guidelines)
  • Current use of inhaled 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00029510

Locations
United States, California
University of California at Davis School of Medicine, Ticon 1, Suite 100B, 2000 Stockton Blvd
Sacramento, California, United States, 95817
Sponsors and Collaborators
Investigators
Principal Investigator: Judith S Stern, Sc.D. University of California, Davis
  More Information

No publications provided by National Center for Complementary and Alternative Medicine (NCCAM)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00029510     History of Changes
Other Study ID Numbers: R01 AT000652-02
Study First Received: January 14, 2002
Last Updated: August 17, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014