Muscle Cramp
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMagTabSR
MagTabSR/placebo 168 mgs BID for 6 six weeks
DIETARY_SUPPLEMENTPlacebo
MagTabSR/placebo 168 mgs BID for 6 six weeks
Sponsors
Corewell Health East
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Participant flow
Recruitment details
Recruitment took place in a private practice clinic between April 15, 2009, and October 5, 2009. Potential study patients responded to a radio advertisement for the study.
Pre-assignment details
Patients consented were asked to keep a daily diary for 1 week which documented frequency, duration, and severity of leg cramps. Blood was also drawn during this visit to assure values within range. At the second visit, patients who were within range for labs and meet the frequency/duration/severity of leg cramps were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Magnesium Tablet SR (MagTabSR) MagTabSR is 168mg taken 2 times per day for 30 days | 20 |
| Sugar Pill Sugar pill is taken 2 times per day for 30 days | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Sugar Pill | Magnesium Tablet SR (MagTabSR) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 13 Participants | 13 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 14 Participants |
| Age Continuous | 66.00 years STANDARD_DEVIATION 9.3 | 67.25 years STANDARD_DEVIATION 9.9 | 66.62 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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).
Time frame: 30 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Magnesium Tablet SR (MagTabSR) | Change in Frequency of Leg Cramps | .99 Cramps per week | Standard Deviation 1.13 |
| Sugar Pill | Change in Frequency of Leg Cramps | .53 Cramps per week | Standard Deviation 0.52 |
Primary
Frequency/Duration of Muscle Cramps
Time frame: 30 days