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Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

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ClinicalTrials.gov Identifier: NCT00963638
Recruitment Status : Completed
First Posted : August 21, 2009
Results First Posted : June 13, 2011
Last Update Posted : October 1, 2012
Sponsor:
Information provided by (Responsible Party):
Rosenbaum, Lewis MD, William Beaumont Hospitals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Muscle Cramp
Interventions Dietary Supplement: MagTabSR
Dietary Supplement: Placebo
Enrollment 40
Recruitment Details 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 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.
Arm/Group Title Magnesium Tablet SR (MagTabSR) Sugar Pill
Hide Arm/Group Description MagTabSR is 168mg taken 2 times per day for 30 days Sugar pill is taken 2 times per day for 30 days
Period Title: Overall Study
Started 20 20
Completed 20 20
Not Completed 0 0
Arm/Group Title Magnesium Tablet SR (MagTabSR) Sugar Pill Total
Hide Arm/Group Description MagTabSR is 168mg taken 2 times per day for 30 days Sugar pill is taken 2 times per day for 30 days Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  35.0%
7
  35.0%
14
  35.0%
>=65 years
13
  65.0%
13
  65.0%
26
  65.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
67.25  (9.9) 66.00  (9.3) 66.62  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
10
  50.0%
13
  65.0%
23
  57.5%
Male
10
  50.0%
7
  35.0%
17
  42.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Change in Frequency of Leg Cramps
Hide Description 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).
Time Frame 30 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Magnesium Tablet SR (MagTabSR) Sugar Pill
Hide Arm/Group Description:
MagTabSR is 168mg taken 2 times per day for 30 days
Sugar pill is taken 2 times per day for 30 days
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: Cramps per week
.99  (1.13) .53  (.52)
2.Primary Outcome
Title Frequency/Duration of Muscle Cramps
Hide Description [Not Specified]
Time Frame 30 days
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Magnesium Tablet SR (MagTabSR) Sugar Pill
Hide Arm/Group Description MagTabSR is 168mg taken 2 times per day for 30 days Sugar pill is taken 2 times per day for 30 days
All-Cause Mortality
Magnesium Tablet SR (MagTabSR) Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Magnesium Tablet SR (MagTabSR) Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Magnesium Tablet SR (MagTabSR) Sugar Pill
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
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
Responsible Party: Rosenbaum, Lewis MD, William Beaumont Hospitals
ClinicalTrials.gov Identifier: NCT00963638     History of Changes
Other Study ID Numbers: HIC #2008-287
First Submitted: August 18, 2009
First Posted: August 21, 2009
Results First Submitted: April 19, 2011
Results First Posted: June 13, 2011
Last Update Posted: October 1, 2012