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.

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Key information

Conditions

Muscle Cramp Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MagTabSR

Dietary Supplement

MagTabSR/placebo 168 mgs BID for 6 six weeks

Placebo

Dietary Supplement

MagTabSR/placebo 168 mgs BID for 6 six weeks

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Corewell Health East

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Aug 21, 2009
Registry last updated: Oct 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed