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.

Study Overview

• Status: Completed
• Conditions: Muscle Cramp
• Intervention / Treatment: Dietary supplement: MagTabSR; Dietary supplement: Placebo

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: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sugar Pill	Dietary supplement: Placebo; MagTabSR/placebo 168 mgs BID for 6 six weeks
Experimental: MagTabSR	Dietary supplement: MagTabSR; MagTabSR/placebo 168 mgs BID for 6 six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	30 days
Frequency/Duration of Muscle Cramps		30 days

Collaborators and Investigators

• Sponsor: William Beaumont Hospitals
• Investigators: Principal Investigator: Lewis Rosenbaum, MD, Physician

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): November 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: August 18, 2009
• First Submitted That Met QC Criteria: August 20, 2009
• First Posted (Estimate): August 21, 2009

Study Record Updates

• Last Update Posted (Estimate): October 1, 2012
• Last Update Submitted That Met QC Criteria: September 19, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Spasm; Muscle Cramp
• Other Study ID Numbers: HIC #2008-287