Exploring the Role of Magnesium in Rest Cramps
This study has been completed.
Sponsor:
University of British Columbia
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Rest Cramps |
Drug: Intravenous Infusion of Magnesium Sulfate |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Magnesium Status & Effect of Magnesium Infusions on Rest Cramps |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 54 |
| Study Start Date: | January 2007 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Intravenous Infusion of Magnesium Sulfate
See 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.
Eligibility| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423540
Locations
| Canada, British Columbia | |
| Richmond Hospital | |
| Richmond, British Columbia, Canada, V7C 4W7 | |
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health Research Institute
Investigators
| Principal Investigator: | Garrison Scott, MD | University of British Columbia |
More Information
No publications provided
| Responsible Party: | Dr. Scott Garrison, University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00423540 History of Changes |
| Other Study ID Numbers: | H06-03345, Health Canada #9427-R1243-21C |
| Study First Received: | January 16, 2007 |
| Last Updated: | December 9, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of British Columbia:
|
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 |
Additional relevant MeSH terms:
|
Muscle Cramp Muscular Diseases Musculoskeletal Diseases Neuromuscular Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Magnesium Sulfate Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Anesthetics Central Nervous System Depressants Anti-Arrhythmia Agents Cardiovascular Agents Anticonvulsants Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Tocolytic Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 16, 2013