AzTrials
AzTrials

AsthmaPhase 2NCT00029510

Magnesium and Asthma - Clinical Trials

A Phase 2 study testing Magnesium in people with Asthma, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
What is being tested?
Magnesium
How many people
240 participants
Where
1 siteUnited States
Study dates
May 2002to Jun 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California at Davis School of Medicine, Ticon 1, Suite 100B, 2000 Stockton Blvd

    Sacramento, California, 95817

Other trials in United States

About this study

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.

Read the 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.

Conditions
Asthma
Being tested
Magnesium
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MagnesiumDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jan 2002 (estimated)
  2. Study startMay 2002
  3. Study completionJun 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
240 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00029510
Sponsor's protocol ID
R01AT000652-02
Status last verified
Jul 2006
First submitted
14 Jan 2002
Last updated
18 Aug 2006
Results posted
No

Publications

  • Kazaks AG, Uriu-Adams JY, Albertson TE, Shenoy SF, Stern JS. Effect of oral magnesium supplementation on measures of airway resistance and subjective assessment of asthma control and quality of life in men and women with mild to moderate asthma: a randomized placebo controlled trial. J Asthma. 2010 Feb;47(1):83-92. doi: 10.3109/02770900903331127.

    PubMed 20100026

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Magnesium in people with Asthma, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00029510, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2006.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in