Magnesium and melatonin nightly supplement for nighttime leg cramps and poor sleep

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study tests a multi-ingredient supplement containing magnesium and melatonin versus placebo over 8 weeks. Participants are randomly assigned to take the product or a matching placebo nightly for 6 weeks and wear an Oura Ring to track sleep, with data collected via a smartphone app. All participation is remote, with home delivery of the supplement and wearable, and no required travel to a clinic. The study screens adults 40–75 with self-reported poor sleep quality and nocturnal leg cramps, and requires smartphone access and home Wi-Fi connectivity for app use. Primary outcomes focus on sleep quality and cramp frequency as measured by self-reports and wearable data.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 40-75 years
* Self-reported poor sleep quality (PSQI \>5) at screening
* Self-reported nocturnal leg cramp averaging ≥4 episodes per fortnight at screening
* Capacity to understand and provide electronic informed consent
* Willing to wear an Oura Ring wearable device continuously throughout the study period
* Access to a smartphone/tablet with iOS 15 or higher and Android 9 or higher and willing to install and use the Oura and Trialflare applications
* 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

Exclusion Criteria:

* Current or recent (within 4 weeks of randomisation) use of melatonin, magnesium, or other supplements specifically taken for sleep or leg cramps or listed as an ingredient of the intervention supplement.
* Current use of any prescription medication
* Diagnosed sleep disorder (e.g. obstructive sleep apnoea, restless legs syndrome, insomnia disorder)
* Known or suspected secondary cause of nocturnal leg cramps (e.g. peripheral vascular disease, neurological condition, renal impairment, thyroid disorder)
* Any current or prior diagnosis of:
* Cancer or malignancy of any kind (prior malignancy is not exclusionary if the participant is in confirmed remission and has completed all treatment)
* Cardiovascular disease (e.g. hypertension, coronary artery disease, heart failure, arrhythmia, stroke, peripheral vascular disease)
* Autoimmune disorder (e.g. rheumatoid arthritis, lupus, multiple sclerosis)
* Gastrointestinal disorder (e.g. IBS, malabsorption syndromes)
* Neurological disorder (e.g. epilepsy, Parkinson's disease, dementia)
* Hepatic or renal impairment
* Diabetes mellitus (type 1 or type 2)
* Severe psychiatric disorder (e.g. schizophrenia, bipolar disorder)
* Myasthenia Gravis
* Known hypersensitivity or allergy to any ingredient in the active or placebo product
* Rotating shift work or irregular sleep patterns
* Current participation in another interventional clinical trial
* Inability to comply with study procedures or remote visit schedule
* Breastfeeding, pregnant, or planning to become pregnant during the study period

Where it's running

• Remote participation (home-based, no site visits)
  Birmingham, Alabama, United States Recruiting
• Remote participation (home-based, no site visits)
  Little Rock, Arkansas, United States Recruiting
• Remote participation (home-based, no site visits)
  Palm Beach Gardens, Florida, United States Recruiting
• Remote participation (home-based, no site visits)
  Atlanta, Georgia, United States Recruiting
• Remote participation (home-based, no site visits)
  Charlotte, North Carolina, United States Recruiting
• Remote participation (home-based, no site visits)
  Charleston, South Carolina, United States Recruiting

Study contacts

• Study coordinator: MISIT Study Team
• Email: misit@studysetgo.com
• Phone: +18886119860

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.