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Magnesium and Melatonin for Nighttime Leg Cramps and Sleep

This study is looking into whether a nutritional supplement called Mag R&R, which contains magnesium and melatonin, can improve sleep quality for adults who have trouble sleeping because of nighttime leg cramps. You might be able to join if you are between 40 and 75 years old, report poor sleep, and experience at least four nighttime leg cramps every two weeks. The study will measure your sleep quality using a questionnaire called the Pittsburgh Sleep Quality Index (PSQI) from when you start until the end of the 6-week treatment period. The current status of this study is unclear, and it plans to enroll 50 participants.

Study design
This is an interventional study where 50 participants will be randomly assigned to receive either the Mag R&R supplement or a placebo (an inactive look-alike). The study is blinded, meaning neither you nor the researchers will know which you are taking.
What's involved
Your participation will last 8 weeks. You will take either the supplement or placebo every night before bed for 6 weeks and continuously wear an Oura Ring device throughout the study.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, sleep quality, is measured from enrollment to the end of treatment at 6 weeks. It is not specified if there is follow-up after this 6-week period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07651514

The Effect of a Daily Magnesium and Melatonin Supplement on Sleep Quality in People With Nighttime Leg Cramps

Recruiting
NAAges 40–75InterventionalTreatment
StudySetGo
~50 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Magnesium and melatonin based multi-ingredient dietary supplementationPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pittsburgh Sleep Quality Index (PSQI)
Measured over From enrollment to the end of treatment at 6 weeks

Conditions

Poor Sleep Quality
Leg Cramps, Nocturnal

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NCT07651514

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • StudySetGo Decentralised team

    Palm Beach Gardens, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Tom Jameson, PhD
[email protected]
+447794865520
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Pittsburgh Sleep Quality Index (PSQI)From enrollment to the end of treatment at 6 weeks

    The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire assessing sleep quality over the past month. Scores range from 0 to 21, where higher scores indicate poorer sleep quality.