Could a Magnesium-Melatonin combo soothe nighttime leg cramps and improve sleep?
NCT ID NCT07651514
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study investigates whether a daily supplement containing magnesium and melatonin can improve sleep quality in adults aged 40 to 75 who experience poor sleep due to nighttime leg cramps. Over 8 weeks, participants take either the supplement or a placebo each night and wear an Oura Ring to track sleep. They also complete short questionnaires via a smartphone app, all from home.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Magnesium and melatonin based multi-ingredient dietary supplement
- What this could lead to
- If it works, this could offer a simple, non-prescription option to improve sleep for people troubled by nighttime leg cramps.
- What could go wrong
- This is a small, early-stage trial with only 50 participants. The supplement may prove no better than a placebo, and individual results may vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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StudySetGo Decentralised team
RECRUITINGPalm Beach Gardens, Florida, 33418, United States
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