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Exploring the Role of Magnesium in Rest Cramps

NCT ID: NCT00423540

Last Updated: 2008-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-11-30

Brief Summary

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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

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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.

Conditions

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Rest Cramps

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Intravenous Infusion of Magnesium Sulfate

See Detailed Description.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vancouver Coastal Health Research Institute

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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University of British Columbia

Principal Investigators

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Garrison Scott, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Richmond Hospital

Richmond, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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Health Canada #9427-R1243-21C

Identifier Type: -

Identifier Source: secondary_id

H06-03345

Identifier Type: -

Identifier Source: org_study_id