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Exploring the Role of Magnesium in Rest Cramps

This study is currently recruiting participants.
Verified by University of British Columbia, September 2008

Sponsors and Collaborators: University of British Columbia
Vancouver Coastal Health Research Institute
Information provided by: University of British Columbia
ClinicalTrials.gov Identifier: NCT00423540
  Purpose

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.


Condition Intervention
Rest Cramps
Drug: Intravenous Infusion of Magnesium Sulfate

MedlinePlus related topics:   Muscle Cramps   

Drug Information available for:   Magnesium    Magnesium sulfate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Magnesium Status & Effect of Magnesium Infusions on Rest Cramps

Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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). [ Time Frame: See above ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessment of magnesium status at trial entry as determined by 24 hour fractional excretion of magnesium on day 1 of infusions. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • Subjective assessment as to whether cramps were unchanged, more, or less frequent /painful/"bothersome" over the 3 months. following infusions. [ Time Frame: See above ] [ Designated as safety issue: No ]
  • Overall quality of life changes as measured by an SF36 questionnaire. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment:   54
Study Start Date:   January 2007
Estimated Study Completion Date:   December 2008
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Drug: Intravenous Infusion of Magnesium Sulfate
    See Detailed Description.
Detailed 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.

  Eligibility
Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Criteria

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423540

Contacts
Contact: Garrison Scott, MD     604-271-0910     sgarrison@telus.net    

Locations
Canada, British Columbia
Richmond Hospital     Recruiting
      Richmond, British Columbia, Canada, V7C 4W7
      Contact: Scott Garrison, MD     604-271-0910     sgarrison@telus.net    
      Principal Investigator: Scott Garrison, MD            

Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health Research Institute

Investigators
Principal Investigator:     Garrison Scott, MD     University of British Columbia    
  More Information


Responsible Party:   University of British Columbia ( Dr. Scott Garrison )
Study ID Numbers:   H06-03345, Health Canada #9427-R1243-21C
First Received:   January 16, 2007
Last Updated:   September 22, 2008
ClinicalTrials.gov Identifier:   NCT00423540
Health Authority:   Canada: Health Canada

Keywords provided by University of British Columbia:
magnesium infusion  
magnesium sulfate  
rest cramps  
nocturnal leg cramps  
muscle cramps  
fractional urinary excretion  
urinary excretion  
24 hour urine  
serum magnesium  
magnesium deficiency  
family practice
general practice
richmond
cramp frequency
magnesium status
urinary magnesium
cramp diary
sf 36
sf 36

Study placed in the following topic categories:
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Magnesium Sulfate
Neurologic Manifestations
Muscle Cramp

Additional relevant MeSH terms:
Neuromuscular Manifestations
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Calcium Channel Blockers
Anesthetics
Central Nervous System Depressants
Reproductive Control Agents
Cardiovascular Agents
Pharmacologic Actions
Membrane Transport Modulators
Tocolytic Agents
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on October 22, 2008




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