Exploring the Role of Magnesium in Rest Cramps
Not Applicable
Completed
- Conditions
- Rest Cramps
- Registration Number
- NCT00423540
- Lead Sponsor
- University of British Columbia
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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). See above
- Secondary Outcome Measures
Name Time Method 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. See above Overall quality of life changes as measured by an SF36 questionnaire.
Trial Locations
- Locations (1)
Richmond Hospital
🇨🇦Richmond, British Columbia, Canada