Trial Outcomes & Findings for Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps (NCT NCT00963638)

NCT ID: NCT00963638

Last Updated: 2012-10-01

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2012-10-01

Participant Flow

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.

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.

Participant milestones

Measure	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
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps

Baseline characteristics by cohort

Measure	Magnesium Tablet SR (MagTabSR) n=20 Participants MagTabSR is 168mg taken 2 times per day for 30 days	Sugar Pill n=20 Participants Sugar pill is taken 2 times per day for 30 days	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Age Continuous	67.25 years STANDARD_DEVIATION 9.9 • n=5 Participants	66.00 years STANDARD_DEVIATION 9.3 • n=7 Participants	66.62 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	13 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

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).

Outcome measures

Measure	Magnesium Tablet SR (MagTabSR) n=20 Participants MagTabSR is 168mg taken 2 times per day for 30 days	Sugar Pill n=20 Participants Sugar pill is taken 2 times per day for 30 days
Change in Frequency of Leg Cramps	.99 Cramps per week Standard Deviation 1.13	.53 Cramps per week Standard Deviation .52

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Outcome data not reported

Adverse Events

Magnesium Tablet SR (MagTabSR)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Catherine Coleman, RN, BSN

William Beaumont Hospitals

Phone: 248-655-5865

Email: cjcoleman@beaumont.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place