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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00963638
Other study ID # HIC #2008-287
Secondary ID
Status Completed
Phase N/A
First received August 18, 2009
Last updated September 19, 2012
Start date April 2009
Est. completion date November 2009

Study information

Verified date September 2012
Source William Beaumont Hospitals
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

Chronic leg cramps are prevalent among the aging population affecting sleep patterns and quality of life. Magnesium deficiency may cause muscle weakness and cramps. Magnesium supplementation will be evaluated for the relief and/or improvement of symptoms. The primary objective is to evaluate the efficacy of magnesium supplementation, MagTabSR, 168mg's twice a day, for the relief and/or improvement in the frequency, duration, intensity of leg cramps. Secondary objectives are to evaluate the improvement in sleep disturbances and quality of life.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 2009
Est. primary completion date November 2009
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria:

- 40-85 Years Old

- No Kidney Impairment

- 2 or more leg cramps per week for last 30 days

Exclusion Criteria:

- < 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
MagTabSR
MagTabSR/placebo 168 mgs BID for 6 six weeks
Placebo
MagTabSR/placebo 168 mgs BID for 6 six weeks

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
William Beaumont Hospitals

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary Frequency/Duration of Muscle Cramps 30 days Yes
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