Exploring the Role of Magnesium in Rest Cramps - Full Text View

Sponsor:	University of British Columbia
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Muscle Cramps

Drug Information available for: Magnesium sulfate Magnesium

U.S. FDA Resources

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:

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

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:	University of British Columbia ( Dr. Scott Garrison )
Study ID Numbers:	H06-03345, Health Canada #9427-R1243-21C
Study First Received:	January 16, 2007
Last Updated:	December 9, 2008
ClinicalTrials.gov Identifier:	NCT00423540 History of Changes
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

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Magnesium Sulfate
Physiological Effects of Drugs
Anesthetics
Calcium Channel Blockers
Reproductive Control Agents
Membrane Transport Modulators
Signs and Symptoms
Musculoskeletal Diseases
Tocolytic Agents
Sensory System Agents
Therapeutic Uses
Analgesics

Anti-Arrhythmia Agents
Neuromuscular Manifestations
Nervous System Diseases
Central Nervous System Depressants
Cardiovascular Agents
Muscle Cramp
Pharmacologic Actions
Muscular Diseases
Neurologic Manifestations
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 30, 2009