Rest Cramps
Conditions
Keywords
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
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.
Interventions
DRUGIntravenous Infusion of Magnesium Sulfate
See Detailed Description.
Sponsors
Vancouver Coastal Health Research Institute
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Canada
Outcome results
None listed