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
  Purpose

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.


Condition Intervention
Muscle Cramp
Dietary Supplement: MagTabSR
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

Resource links provided by NLM:


Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: April 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MagTabSR Dietary Supplement: MagTabSR
MagTabSR/placebo 168 mgs BID for 6 six weeks
Placebo Comparator: Sugar Pill Dietary Supplement: Placebo
MagTabSR/placebo 168 mgs BID for 6 six weeks

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963638

Sponsors and Collaborators
William Beaumont Hospitals
Investigators
Principal Investigator: Lewis Rosenbaum, MD Physician
  More Information

No publications provided

Responsible Party: Rosenbaum, Lewis MD, Principal Investigator, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00963638     History of Changes
Other Study ID Numbers: HIC #2008-287
Study First Received: August 18, 2009
Results First Received: April 19, 2011
Last Updated: September 19, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Muscle Cramp
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 10, 2014