Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
The goal of this study is to evaluate the effectiveness of magnesium supplements (MagTabSR 168 mgs twice daily) for relief and/or improvement in the frequency, duration, and intensity of chronic leg cramps. Improvement in sleep disturbances and quality of life will also be evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2009
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
June 13, 2011
CompletedOctober 1, 2012
September 1, 2012
7 months
August 18, 2009
April 19, 2011
September 19, 2012
Conditions
Outcome Measures
Primary Outcomes (2)
Change in Frequency of Leg Cramps
Patients recorded number of leg cramps daily. The primary outcome measure was changed to the weekly average number of daily leg cramps for the first 28 days (4 weeks) after the start of treatment compared to the week prior to treatment (week 4 - pretreatment baseline).
30 days
Frequency/Duration of Muscle Cramps
30 days
Study Arms (2)
MagTabSR
EXPERIMENTALSugar Pill
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Years Old
- No Kidney Impairment
- or more leg cramps per week for last 30 days
You may not qualify if:
- \< 40 or \> 85 Years Old
- Kidney Impairment
- \< 2 leg cramps per week for last 30 days
- Enrolled in another research study
- History of seizure disorder
- Current treatment with Lithium
- Malabsorption or major intestinal disorders
- Significantly elevated magnesium level
- History of allergy to magnesium compound
- Use of Quinine for leg cramps
- History of significant diarrhea
- History of drug or alcohol abuse in the last 2 years
- Currently diagnosed with a terminal illness
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Catherine Coleman, RN, BSN
- Organization
- William Beaumont Hospitals
Study Officials
- PRINCIPAL INVESTIGATOR
Lewis Rosenbaum, MD
Physician
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 18, 2009
First Posted
August 21, 2009
Study Start
April 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
October 1, 2012
Results First Posted
June 13, 2011
Record last verified: 2012-09