Muscle CrampNCT00963638
Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps
A study testing MagTabSR in people with Muscle Cramp, run by Corewell Health East.
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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Muscle Cramp
- What is being tested?
- MagTabSR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Nov 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 40-85 Years Old
- No Kidney Impairment
- 2 or more leg cramps per week for last 30 days
Who cannot join
- < 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
Show all 13Show fewer
- 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
About this study
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.
Read the detailed 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.
- Conditions
- Muscle Cramp
- Being tested
- MagTabSR, Placebo
- Medical subject headings
- Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagTabSRDietary supplement
MagTabSR/placebo 168 mgs BID for 6 six weeks
PlaceboDietary supplement
MagTabSR/placebo 168 mgs BID for 6 six weeks
| Study group | Role | What they receive |
|---|---|---|
| MagTabSR | Experimental | Not described Receives: Dietary Supplement: MagTabSR |
| Sugar Pill | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 days
Frequency/Duration of Muscle Cramps
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Muscle CrampStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosenbaum, Lewis MD, Corewell Health East
- Investigators
- Lewis Rosenbaum, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963638
- Sponsor's protocol ID
- HIC #2008-287
- Status last verified
- Sep 2012
- First submitted
- 18 Aug 2009
- Last updated
- 1 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beneficial Effects of Magnesium Supplementation On Idiopathic Muscle Cramps
- ClinicalTrials.gov ID
- NCT00963638
- Acronym / sponsor ID
- HIC #2008-287
- Conditions
- Muscle Cramp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 21 Aug 2009 (estimated)
- Results
- Posted 13 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MagTabSR | Experimental | Dietary Supplement: MagTabSR |
| Sugar Pill | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40-85 Years Old
- No Kidney Impairment
- 2 or more leg cramps per week for last 30 days
Key exclusion criteria (13 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagTabSRMagTabSR/placebo 168 mgs BID for 6 six weeks | Dietary supplement | MagTabSR |
| PlaceboMagTabSR/placebo 168 mgs BID for 6 six weeks | Dietary supplement | Sugar Pill |
Primary outcome
Change in Frequency of Leg Cramps
Time frame: 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).
Frequency/Duration of Muscle Cramps
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lewis Rosenbaum, MD principal investigator
Physician
Questions about this trial
What is this clinical trial studying?
A study testing MagTabSR in people with Muscle Cramp, run by Corewell Health East.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jun 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Frequency of Leg Cramps (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2012.