Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029510
Status:
COMPLETED
Last Update Posted:
2006-08-18
First Post:
2002-01-14
Brief Title:
Magnesium and Asthma - Clinical Trials
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Magnesium and Asthma - Clinical Trials
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 12 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
Detailed Description:
Over the past twenty years a number of studies of acute bronchial asthma have shown that iv 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 12 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 challengein 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 intakestatus 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None