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Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rosenbaum, Lewis MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00963638
First received: August 18, 2009
Last updated: September 19, 2012
Last verified: September 2012

August 18, 2009
September 19, 2012
April 2009
November 2009   (final data collection date for primary outcome measure)
  • Change in Frequency of Leg Cramps [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Frequency/Duration of Muscle Cramps [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00963638 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps
Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Muscle Cramp
  • Dietary Supplement: MagTabSR
    MagTabSR/placebo 168 mgs BID for 6 six weeks
  • Dietary Supplement: Placebo
    MagTabSR/placebo 168 mgs BID for 6 six weeks
  • Experimental: MagTabSR
    Intervention: Dietary Supplement: MagTabSR
  • Placebo Comparator: Sugar Pill
    Intervention: Dietary Supplement: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
40 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00963638
HIC #2008-287
No
Rosenbaum, Lewis MD, William Beaumont Hospitals
William Beaumont Hospitals
Not Provided
Principal Investigator: Lewis Rosenbaum, MD Physician
William Beaumont Hospitals
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP