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

January 16, 2007
December 9, 2008
January 2007
November 2008   (final data collection date for primary outcome measure)
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 ]
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).
Complete list of historical versions of study NCT00423540 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Assessment of magnesium status at trial entry as determined by 24 hour fractional excretion of magnesium on day 1 of infusions.
  • Subjective assessment as to whether cramps were unchanged, more, or less frequent /painful/”bothersome” over the 3 months. following infusions.
  • Overall quality of life changes as measured by an SF36 questionnaire.
Not Provided
Not Provided
 
Exploring the Role of Magnesium in Rest Cramps
Magnesium Status & Effect of Magnesium Infusions on Rest Cramps

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Rest Cramps
Drug: Intravenous Infusion of Magnesium Sulfate
See Detailed Description.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
November 2008
November 2008   (final data collection date for primary outcome measure)

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
Both
19 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00423540
H06-03345, Health Canada #9427-R1243-21C
No
Dr. Scott Garrison, University of British Columbia
University of British Columbia
Vancouver Coastal Health Research Institute
Principal Investigator: Garrison Scott, MD University of British Columbia
University of British Columbia
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP