Exploring the Role of Magnesium in Rest Cramps

This study has been completed.
Sponsor:
Collaborator:
Vancouver Coastal Health Research Institute
Information provided by:
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00423540
First received: January 16, 2007
Last updated: December 9, 2008
Last verified: December 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Magnesium Status & Effect of Magnesium Infusions on Rest Cramps

Resource links provided by NLM:


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
Study Completion Date: November 2008
Primary Completion Date: November 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Study First Received: January 16, 2007
Last Updated: December 9, 2008
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

Additional relevant MeSH terms:
Muscle Cramp
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on August 28, 2014