Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Change in Frequency of Leg Cramps
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40-85 Years Old
- •No Kidney Impairment
- •2 or more leg cramps per week for last 30 days
排除标准
- •< 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
结局指标
主要结局
Change in Frequency of Leg Cramps
时间窗: 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
时间窗: 30 days
次要结局
未报告次要终点
研究者
Rosenbaum, Lewis MD
Principal Investigator
William Beaumont Hospitals