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Could a Magnesium-Melatonin combo soothe nighttime leg cramps and improve sleep?

NCT ID NCT07651514

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

40 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Sleep-Wake Transition Disorders

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • StudySetGo Decentralised team

    RECRUITING

    Palm Beach Gardens, Florida, 33418, United States

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