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Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

Primary Purpose

Muscle Cramp

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MagTabSR
Placebo
Sponsored by
William Beaumont Hospitals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Cramp

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    MagTabSR

    Sugar Pill

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Frequency of Leg Cramps
    Patients recorded number of leg cramps daily. The primary outcome measure was changed to the weekly average number of daily leg cramps for the first 28 days (4 weeks) after the start of treatment compared to the week prior to treatment (week 4 - pretreatment baseline).
    Frequency/Duration of Muscle Cramps

    Secondary Outcome Measures

    Full Information

    First Posted
    August 18, 2009
    Last Updated
    September 19, 2012
    Sponsor
    William Beaumont Hospitals
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00963638
    Brief Title
    Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps
    Official Title
    Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2009 (undefined)
    Primary Completion Date
    November 2009 (Actual)
    Study Completion Date
    November 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    William Beaumont Hospitals

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Muscle Cramp

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MagTabSR
    Arm Type
    Experimental
    Arm Title
    Sugar Pill
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    MagTabSR
    Intervention Description
    MagTabSR/placebo 168 mgs BID for 6 six weeks
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    MagTabSR/placebo 168 mgs BID for 6 six weeks
    Primary Outcome Measure Information:
    Title
    Change in Frequency of Leg Cramps
    Description
    Patients recorded number of leg cramps daily. The primary outcome measure was changed to the weekly average number of daily leg cramps for the first 28 days (4 weeks) after the start of treatment compared to the week prior to treatment (week 4 - pretreatment baseline).
    Time Frame
    30 days
    Title
    Frequency/Duration of Muscle Cramps
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lewis Rosenbaum, MD
    Organizational Affiliation
    Physician
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

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