| 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.
|
| |
| 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 |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Rest Cramps |
| Drug: Intravenous Infusion of Magnesium Sulfate |
| |
| |
| |
| 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
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| Both |
| 19 Years and older |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| Canada |
| |
| NCT00423540 |
| Dr. Scott Garrison, University of British Columbia |
| H06-03345, Health Canada #9427-R1243-21C |
| University of British Columbia |
| Vancouver Coastal Health Research Institute |
| Principal Investigator: |
Garrison Scott, MD |
University of British Columbia |
|
|
| University of British Columbia |
| December 2008 |
