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Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

NCT ID: NCT00963638

Last Updated: 2012-10-01

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-11-30

Brief Summary

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The goal of this study is to evaluate the effectiveness of magnesium supplements (MagTabSR 168 mgs twice daily) for relief and/or improvement in the frequency, duration, and intensity of chronic leg cramps. Improvement in sleep disturbances and quality of life will also be evaluated.

Detailed Description

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Chronic leg cramps are prevalent among the aging population affecting sleep patterns and quality of life. Magnesium deficiency may cause muscle weakness and cramps. Magnesium supplementation will be evaluated for the relief and/or improvement of symptoms. The primary objective is to evaluate the efficacy of magnesium supplementation, MagTabSR, 168mg's twice a day, for the relief and/or improvement in the frequency, duration, intensity of leg cramps. Secondary objectives are to evaluate the improvement in sleep disturbances and quality of life.

Conditions

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Muscle Cramp

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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MagTabSR

Group Type EXPERIMENTAL

MagTabSR

Intervention Type DIETARY_SUPPLEMENT

MagTabSR/placebo 168 mgs BID for 6 six weeks

Sugar Pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

MagTabSR/placebo 168 mgs BID for 6 six weeks

Interventions

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MagTabSR

MagTabSR/placebo 168 mgs BID for 6 six weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

MagTabSR/placebo 168 mgs BID for 6 six weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 40-85 Years Old
* No Kidney Impairment
* 2 or more leg cramps per week for last 30 days

Exclusion Criteria

* \< 40 or \> 85 Years Old
* Kidney Impairment
* \< 2 leg cramps per week for last 30 days
* Enrolled in another research study
* History of seizure disorder
* Current treatment with Lithium
* Malabsorption or major intestinal disorders
* Significantly elevated magnesium level
* History of allergy to magnesium compound
* Use of Quinine for leg cramps
* History of significant diarrhea
* History of drug or alcohol abuse in the last 2 years
* Currently diagnosed with a terminal illness
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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William Beaumont Hospitals

OTHER

Sponsor Role lead

Responsible Party

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Rosenbaum, Lewis MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lewis Rosenbaum, MD

Role: PRINCIPAL_INVESTIGATOR

Physician

Countries

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United States

Other Identifiers

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HIC #2008-287

Identifier Type: -

Identifier Source: org_study_id