RecruitingPhase 4NCT06902285
Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
Use of Magnesium-L-Threonate to Improve Subjective Sleep Quality After Total Joint Arthroplasties: Randomized Controlled Clinical Trial
Sponsor
University of Miami
Enrollment
64 participants
Start Date
Apr 21, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The study team is conducting a study to see if Magnesium-L-Threonate (MgT) can help improve how well participants sleep and reduce pain after total joint replacement surgery
Eligibility
Min Age: 18 Years
Inclusion Criteria4
- Patients undergoing primary total knee or hip arthroplasty at the University of Miami Hospital
- Patients > 18 years of age
- Subjects must be capable of providing informed consent
- English or Spanish-speaking
Exclusion Criteria11
- Previous total joint arthroplasty at the surgical site
- History of sleeping disorders, including narcolepsy, sleep apnea, insomnia, parasomnias, and restless leg syndrome.
- History of Complex Regional Pain Syndrome in ipsilateral extremity
- History of demyelinating disorder or neurologic deficit in the affected extremity
- History of psychiatric disorders that could impact sleep, such as untreated depression, bipolar disorder, or schizophrenia.
- Participants taking medications known to cause significant sedation or insomnia.
- Pregnant or breastfeeding
- Being treated for a diagnosis other than primary osteoarthritis (e.g. pelvic/femur fracture)
- Patients with known substance use disorder within 6 months of surgery
- Liver Failure, via clinical diagnosis or international normalized ratio greater than 1.5 or Prothrombin time greater than 40
- Chronic Kidney Disease or glomerular filtration rate less than 30 mL/min
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Interventions
DRUGMagnesium Threonate
Participants will receive a daily 145 mg pill by mouth 30 minutes before going to sleep
OTHERControl
Participants will receive two sugar pills daily by mouth 30 minutes before going to sleep
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06902285
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