NCT00029510

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2 asthma

Timeline
Completed

Started May 2002

Longer than P75 for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 15, 2002

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2002

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

August 18, 2006

Status Verified

July 1, 2006

First QC Date

January 14, 2002

Last Update Submit

August 17, 2006

Conditions

Interventions

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

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

Sacramento, California, 95817, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Asthma

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline EarthElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Judith S Stern, Sc.D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

January 14, 2002

First Posted

January 15, 2002

Study Start

May 1, 2002

Study Completion

June 1, 2006

Last Updated

August 18, 2006

Record last verified: 2006-07

Locations