Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

Muscle Cramp Clinical Trial

Official title:

Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963638
• Other study ID #: HIC #2008-287
• Status: Completed
• Phase: N/A
• First received: August 18, 2009
• Last updated: September 19, 2012
• Start date: April 2009
• Est. completion date: November 2009

Study information

• Verified date: September 2012
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Cramp
• Spasm

Intervention

Dietary Supplement:
• MagTabSR
MagTabSR/placebo 168 mgs BID for 6 six weeks
• Placebo
MagTabSR/placebo 168 mgs BID for 6 six weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Frequency/Duration of Muscle Cramps		30 days	Yes