Exploring the Role of Magnesium in Rest Cramps | NCT00423540

Studies
Exploring the Role of Magnesium in Rest Cramps

NCT00423540

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Dec 10, 2008Estimated

Enrollment

54Estimated

Phase

Not Applicable

Conditions

Rest Cramps

Interventions

Intravenous Infusion of Magnesium Sulfate

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
Health Canada #9427-R1243-21C

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Nov 2008Actual

Completion Date

Nov 2008Actual

First Submitted Date

Jan 16, 2007

First Submission Date that Met QC Criteria

Jan 17, 2007

First Posted Date

Jan 18, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2008

Last Update Posted Date

Dec 10, 2008Estimated

Name	Class
Vancouver Coastal Health Research Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

54Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravenous Infusion of Magnesium Sulfate	Drug	See Detailed Description.

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Garrison Scott, MD	University of British Columbia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Richmond Hospital		Richmond	British Columbia	V7C 4W7	Canada

Condition Browse Module

MeSH Terms

ID	Term
D020922	Sleep-Wake Transition Disorders
D009120	Muscle Cramp
D008275	Magnesium Deficiency

Ancestor Terms

ID	Term
D020447	Parasomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided