Clinical Trial: Exploring the Role of Magnesium in Rest Cramps

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Magnesium Status & Effect of Magnesium Infusions on Rest Cramps

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.

Detailed Summary: 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.
Sponsor: University of British Columbia

Current Primary Outcome: 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 ]

Original Primary Outcome: 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).

Current Secondary Outcome:

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


Original Secondary Outcome:

  • 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.


Information By: University of British Columbia

Dates:
Date Received: January 16, 2007
Date Started: January 2007
Date Completion:
Last Updated: December 9, 2008
Last Verified: December 2008