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
About this trial
This is an interventional treatment trial for Muscle Cramp
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
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
NCT ID
NCT00963638
First Posted
August 18, 2009
Last Updated
September 19, 2012
Sponsor
William Beaumont Hospitals
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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