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

History of Changes

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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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 ]

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2. Primary:

Frequency/Duration of Muscle Cramps [ Time Frame: 30 days ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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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.

Limitations and Caveats

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.

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

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