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Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rosenbaum, Lewis MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00963638
First received: August 18, 2009
Last updated: September 19, 2012
Last verified: September 2012
Results First Received: April 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Muscle Cramp
Interventions: Dietary Supplement: MagTabSR
Dietary Supplement: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment took place in a private practice clinic between April 15, 2009, and October 5, 2009. Potential study patients responded to a radio advertisement for the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients consented were asked to keep a daily diary for 1 week which documented frequency, duration, and severity of leg cramps. Blood was also drawn during this visit to assure values within range. At the second visit, patients who were within range for labs and meet the frequency/duration/severity of leg cramps were randomized.

Reporting Groups
  Description
Magnesium Tablet SR (MagTabSR) MagTabSR is 168mg taken 2 times per day for 30 days
Sugar Pill Sugar pill is taken 2 times per day for 30 days

Participant Flow:   Overall Study
    Magnesium Tablet SR (MagTabSR)     Sugar Pill  
STARTED     20     20  
COMPLETED     20     20  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Magnesium Tablet SR (MagTabSR) MagTabSR is 168mg taken 2 times per day for 30 days
Sugar Pill Sugar pill is taken 2 times per day for 30 days
Total Total of all reporting groups

Baseline Measures
    Magnesium Tablet SR (MagTabSR)     Sugar Pill     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     7     14  
>=65 years     13     13     26  
Age  
[units: years]
Mean ± Standard Deviation
  67.25  ± 9.9     66.00  ± 9.3     66.62  ± 9.5  
Gender  
[units: participants]
     
Female     10     13     23  
Male     10     7     17  
Region of Enrollment  
[units: participants]
     
United States     20     20     40  



  Outcome Measures

1.  Primary:   Change in Frequency of Leg Cramps   [ Time Frame: 30 days ]

2.  Primary:   Frequency/Duration of Muscle Cramps   [ Time Frame: 30 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Catherine Coleman, RN, BSN
Organization: William Beaumont Hospitals
phone: 248-655-5865
e-mail: cjcoleman@beaumont.edu


No publications provided


Responsible Party: Rosenbaum, Lewis MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00963638     History of Changes
Other Study ID Numbers: HIC #2008-287
Study First Received: August 18, 2009
Results First Received: April 19, 2011
Last Updated: September 19, 2012
Health Authority: United States: Institutional Review Board