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Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00963638
Recruitment Status : Completed
First Posted : August 21, 2009
Results First Posted : June 13, 2011
Last Update Posted : October 1, 2012
Sponsor:
Information provided by (Responsible Party):
Rosenbaum, Lewis MD, William Beaumont Hospitals

Tracking Information
First Submitted Date  ICMJE August 18, 2009
First Posted Date  ICMJE August 21, 2009
Results First Submitted Date  ICMJE April 19, 2011
Results First Posted Date  ICMJE June 13, 2011
Last Update Posted Date October 1, 2012
Study Start Date  ICMJE April 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2011)
  • Change in Frequency of Leg Cramps [ Time Frame: 30 days ]
    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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2009)
Frequency/Duration of Muscle Cramps [ Time Frame: 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps
Official Title  ICMJE Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Muscle Cramp
Intervention  ICMJE
  • Dietary Supplement: MagTabSR
    MagTabSR/placebo 168 mgs BID for 6 six weeks
  • Dietary Supplement: Placebo
    MagTabSR/placebo 168 mgs BID for 6 six weeks
Study Arms  ICMJE
  • Experimental: MagTabSR
    Intervention: Dietary Supplement: MagTabSR
  • Placebo Comparator: Sugar Pill
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2011)
40
Original Estimated Enrollment  ICMJE
 (submitted: August 20, 2009)
50
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00963638
Other Study ID Numbers  ICMJE HIC #2008-287
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rosenbaum, Lewis MD, William Beaumont Hospitals
Study Sponsor  ICMJE William Beaumont Hospitals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lewis Rosenbaum, MD Physician
PRS Account William Beaumont Hospitals
Verification Date September 2012

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