Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

Not Applicable

Completed

• Conditions: Muscle Cramp
• Interventions: Dietary Supplement: MagTabSR; Dietary Supplement: Placebo

• Registration Number: NCT00963638
• Lead Sponsor: William Beaumont Hospitals

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 Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-20
• Study First Posted: 2009-08-21
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Results First Submitted: 2011-04-19
• Results First Submitted QC: 2011-05-12
• Results First Posted: 2011-06-13
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-19
• Last Update Posted: 2012-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MagTabSR	MagTabSR	-
Sugar Pill	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Frequency of Leg Cramps	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	30 days