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Exploring the Role of Magnesium in Rest Cramps

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00423540
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : December 10, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Rest Cramps Drug: Intravenous Infusion of Magnesium Sulfate

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Magnesium Status & Effect of Magnesium Infusions on Rest Cramps
Study Start Date : January 2007
Primary Completion Date : November 2008
Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Muscle Cramps
U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Assessment of magnesium status at trial entry as determined by 24 hour fractional excretion of magnesium on day 1 of infusions.
  2. Subjective assessment as to whether cramps were unchanged, more, or less frequent /painful/"bothersome" over the 3 months. following infusions. [ Time Frame: See above ]
  3. Overall quality of life changes as measured by an SF36 questionnaire.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423540


Locations
Canada, British Columbia
Richmond Hospital
Richmond, British Columbia, Canada, V7C 4W7
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: Dr. Scott Garrison, University of British Columbia
ClinicalTrials.gov Identifier: NCT00423540     History of Changes
Other Study ID Numbers: H06-03345
Health Canada #9427-R1243-21C
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: December 10, 2008
Last Verified: December 2008

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

Additional relevant MeSH terms:
Muscle Cramp
Spasm
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents