Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MagTabSR | Experimental |
| |
| Sugar Pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MagTabSR | Dietary Supplement | MagTabSR/placebo 168 mgs BID for 6 six weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Frequency/Duration of Muscle Cramps | 30 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lewis Rosenbaum, MD | Physician | Principal Investigator |
Not provided
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.
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.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Magnesium Tablet SR (MagTabSR) | MagTabSR is 168mg taken 2 times per day for 30 days |
| FG001 | Sugar Pill | Sugar pill is taken 2 times per day for 30 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Magnesium Tablet SR (MagTabSR) | MagTabSR is 168mg taken 2 times per day for 30 days |
| BG001 | Sugar Pill | Sugar pill is taken 2 times per day for 30 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | Cramps per week | 30 days |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magnesium Tablet SR (MagTabSR) | MagTabSR is 168mg taken 2 times per day for 30 days |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Catherine Coleman, RN, BSN | William Beaumont Hospitals | 248-655-5865 | cjcoleman@beaumont.edu |
| ID | Term |
|---|---|
| D009120 | Muscle Cramp |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Dietary Supplement |
MagTabSR/placebo 168 mgs BID for 6 six weeks |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Frequency/Duration of Muscle Cramps | Not Posted | 30 days |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Sugar Pill | Sugar pill is taken 2 times per day for 30 days | 0 | 20 | 0 | 20 |
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |