search
Back to results

Exploring the Role of Magnesium in Rest Cramps

Primary Purpose

Rest Cramps

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intravenous Infusion of Magnesium Sulfate
Sponsored by
University of British Columbia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rest Cramps focused on measuring 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

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Richmond Hospital

Outcomes

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).

Secondary Outcome Measures

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.

Full Information

First Posted
January 16, 2007
Last Updated
December 9, 2008
Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health Research Institute
search

1. Study Identification

Unique Protocol Identification Number
NCT00423540
Brief Title
Exploring the Role of Magnesium in Rest Cramps
Official Title
Magnesium Status & Effect of Magnesium Infusions on Rest Cramps
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of British Columbia
Collaborators
Vancouver Coastal Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rest Cramps
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Intravenous Infusion of Magnesium Sulfate
Intervention Description
See Detailed Description.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Assessment of magnesium status at trial entry as determined by 24 hour fractional excretion of magnesium on day 1 of infusions.
Title
Subjective assessment as to whether cramps were unchanged, more, or less frequent /painful/"bothersome" over the 3 months. following infusions.
Time Frame
See above
Title
Overall quality of life changes as measured by an SF36 questionnaire.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garrison Scott, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Richmond Hospital
City
Richmond
State/Province
British Columbia
ZIP/Postal Code
V7C 4W7
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Exploring the Role of Magnesium in Rest Cramps

We'll reach out to this number within 24 hrs