Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- William Beaumont Hospitals
- Enrollment
- 40
- Primary Endpoint
- Change in Frequency of Leg Cramps
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
MagTabSR
Intervention: MagTabSR (Dietary Supplement)
Sugar Pill
Intervention: Placebo (Dietary Supplement)
Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Rosenbaum, Lewis MD
Principal Investigator
William Beaumont Hospitals