Safety and Efficacy of Magnesium Oxide in Cirrhosis Patients with Muscle Cramps: A Randomized Double-Blind Placebo-Controlled Study
Raj Vuppalanchi, MD
Primary Investigator
Jessica MacLean
Primary Investigator
Brief description of study
It is hypothesized that magnesium oxide supplementation at 400 mg per day for 4 weeks improves muscle cramps in patients with cirrhosis. Cirrhotic patients with muscle cramps and maintaining a mean composite symptom score ? 6 in the run-in period will be randomly assigned to either magnesium oxide supplementation or placebo in a double-blinded fashion. Subjects will use a cramp dairy to collect daily information on severity and frequency of cramps during the previous 2 weeks before starting the intervention (run-in period), 4 weeks of treatment and 4 weeks after the intervention. The primary endpoint is the proportion of patients achieving >50% reduction in the mean composite symptom score (CSS). Secondary endpoints include individual evaluations of frequency and severity of cramps, CLDQ score and Pittsburgh Sleep Quality Index (PSQI). Serum electrolytes and mean arterial pressure will be measured at various intervals before and after the intervention.
Detailed description of study
It is hypothesized that magnesium oxide supplementation at 400 mg per day for 4 weeks improves muscle cramps in patients with cirrhosis. Cirrhotic patients with muscle cramps and maintaining a mean composite symptom score ? 6 in the run-in period will be randomly assigned to either magnesium oxide supplementation or placebo in a double-blinded fashion. Subjects will use a cramp dairy to collect daily information on severity and frequency of cramps during the previous 2 weeks before starting the intervention (run-in period), 4 weeks of treatment and 4 weeks after the intervention. The primary endpoint is the proportion of patients achieving >50% reduction in the mean composite symptom score (CSS). Secondary endpoints include individual evaluations of frequency and severity of cramps, CLDQ score and Pittsburgh Sleep Quality Index (PSQI). Serum electrolytes and mean arterial pressure will be measured at various intervals before and after the intervention.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: cirrhosis
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Age: 100 years or below
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Gender: All