50 Participants NeededMy employer runs this trial

Magnesium + Melatonin for Charley Horse

(MISIT Trial)

Recruiting at 13 trial locations
TJ
CK
MS
CK
Overseen ByChris Koscien, PhD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a supplement containing magnesium and melatonin can improve sleep quality for adults experiencing nighttime leg cramps. Participants will take either the supplement or a placebo each night for six weeks. Eligible participants must experience at least four leg cramp episodes every two weeks and have poor sleep quality. They will wear an Oura Ring for sleep tracking and complete brief app-based questionnaires, all from home. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance sleep quality for many.

Will I have to stop taking my current medications?

Yes, you must stop taking any prescription medications to participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that magnesium and melatonin supplements are usually safe for most people. Magnesium, a mineral, helps muscles and nerves function properly and is often used in supplements without causing side effects. Melatonin, a hormone, aids in better sleep, and many people use it to improve sleep quality, with side effects being rare. Some individuals might experience slight drowsiness or dizziness, but this is uncommon.

Both magnesium and melatonin have been safely used in other supplements, suggesting that their combined use in the study is likely safe for most people. Consulting a healthcare provider before starting any new supplement is always advisable, especially for those with health concerns.12345

Why are researchers excited about this trial?

Researchers are excited about using magnesium and melatonin for treating charley horse cramps because these ingredients offer a new approach compared to current treatments like stretching, hydration, or over-the-counter medications. Magnesium helps relax muscles and improve nerve function, while melatonin is known for its sleep-regulating properties, potentially offering dual benefits for nighttime cramps. This combination could provide a more holistic solution by addressing both the muscle and sleep aspects of the condition, making it a promising option for those who experience frequent nocturnal leg cramps.

What evidence suggests that this treatment might be an effective treatment for nighttime leg cramps?

Research suggests that magnesium may help with muscle cramps by relaxing muscles and blocking calcium, which aids in muscle relaxation. However, some studies have shown that magnesium alone might not be very effective for leg cramps. Melatonin, often used to aid sleep, could improve sleep quality even in the presence of cramps. This trial will test a combination of magnesium and melatonin in a multi-ingredient dietary supplement, potentially addressing both muscle relaxation and improved sleep. Many people have reported that magnesium supplements help reduce cramps and enhance sleep. By combining magnesium and melatonin, this supplement might offer a dual benefit for those experiencing leg cramps at night. Participants in this trial will receive either the magnesium and melatonin supplement or a placebo.678910

Are You a Good Fit for This Trial?

This trial is for adults aged 40-75 living in Florida who have poor sleep and frequent nighttime leg cramps (at least 4 episodes every two weeks). Participants must be able to use a smartphone, wear an Oura Ring, and not have certain health conditions or take related medications.

Inclusion Criteria

Be a resident of and permanently living in Florida with no planned travel across more than one time zone for at least 1 night during the study period
I am between 40 and 75 years old.
Self-reported poor sleep quality (PSQI >5) at screening
See 4 more

Exclusion Criteria

Any current or prior diagnosis of severe psychiatric disorder (e.g. schizophrenia, bipolar disorder)
Known hypersensitivity or allergy to any ingredient in the active or placebo product
Rotating shift work or irregular sleep patterns
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Participants wear an Oura Ring and complete daily app-based questionnaires to establish baseline sleep quality

2 weeks
Remote monitoring and app-based questionnaires

Treatment

Participants take either the nutritional supplement or placebo every night for 6 weeks while wearing an Oura Ring and completing questionnaires

6 weeks
Remote monitoring and app-based questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks
Remote monitoring and app-based questionnaires

What Are the Treatments Tested in This Trial?

Interventions

  • Magnesium and melatonin based multi-ingredient dietary supplementation

Trial Overview

The study tests whether taking a daily supplement with magnesium and melatonin improves sleep quality compared to a placebo. Participants are randomly assigned to either the supplement or placebo group for six weeks, using wearable devices and app-based questionnaires at home.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Magnesium and melatonin based multi-ingredient dietary supplementExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

StudySetGo

Lead Sponsor

Citations

Prevention of leg cramps by using compression stockings ...

It is unlikely that magnesium supplementation provides clinically meaningful cramp prophylaxis to older adults experiencing skeletal muscle cramps.

Magnesium for the Treatment of Nocturnal Leg Cramps A ...

Magnesium was not effective for the treatment of nocturnal leg cramps. The period-effect bias probably occurred because of a combination of the ...

Mag Max for Leg Cramps: Magnesium Support for Better ...

Charley horses and nighttime. Mag Max is formulated to help relax your muscles and support restful sleep, so you can wake up refreshed instead ...

Best magnesium for leg cramps comparison and ...

This guide dissects the science behind magnesium's role in muscle relaxation, evaluates the most bioavailable forms for cramp relief, and ...

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