Exploring the Role of Magnesium in Rest Cramps

Rest Cramps Clinical Trial

Official title:

Magnesium Status & Effect of Magnesium Infusions on Rest Cramps

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00423540
• Other study ID #: H06-03345
• Secondary ID: Health Canada #9
• Status: Completed
• Phase: N/A
• First received: January 16, 2007
• Last updated: December 9, 2008
• Start date: January 2007
• Est. completion date: November 2008

Study information

• Verified date: December 2008
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study sets out to show whether infusions of magnesium can lessen the frequency of rest cramps and to determine whether rest cramp sufferers have a deficiency in magnesium.

Description:

Subjects will be randomized to receive 5 days of 4 hour IV infusions of D5W either with or without 20 mmol magnesium sulfate added. Twenty four hour urinary excretion of magnesium will be determined on the first day of infusions to assess whether magnesium deficiency is present. Ten normal controls will also undergo a single infusion and collection of urine to serve as a comparison group for the urinary excretion data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• =2 leg or foot cramps per week in a 4 week run-in diary

Exclusion Criteria:

• eGFR<50

• Neurologic disease

• Pregnancy

• Heart block

• Bradyarhythmia without pacemaker

• Digoxin use

• Liver disease

• Addison's disease

• History of MI

• CHF

• Absence of detectable reflexes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Cramp
• Rest Cramps
• Spasm

Intervention

Drug:
• Intravenous Infusion of Magnesium Sulfate
See Detailed Description.

Locations

Country	Name	City	State
Canada	Richmond Hospital	Richmond	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	Vancouver Coastal Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the frequency of leg cramps per week (active versus placebo) over the first 30 days post infusions compared to the 30 days prior to randomization (as recorded in patient diaries).		See above	No
Secondary	Assessment of magnesium status at trial entry as determined by 24 hour fractional excretion of magnesium on day 1 of infusions.		Unspecified	No
Secondary	Subjective assessment as to whether cramps were unchanged, more, or less frequent /painful/"bothersome" over the 3 months. following infusions.		See above	No
Secondary	Overall quality of life changes as measured by an SF36 questionnaire.		Unspecified	No