Using Magnesium-L-Threonate to Improve Sleep After Joint Surgery
Use of Magnesium-L-Threonate to Improve Subjective Sleep Quality After Total Joint Arthroplasties: Randomized Controlled Clinical Trial
This study is testing if a magnesium supplement can help improve sleep and reduce pain for people recovering from knee or hip surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT06902285 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of Magnesium-L-Threonate (MgT) on sleep quality and pain reduction in patients who have undergone total knee or hip arthroplasty. Participants will be randomly assigned to receive either MgT or a control treatment. The study aims to determine if MgT can enhance sleep quality post-surgery, which is crucial for recovery and overall well-being. The research is being conducted at the University of Miami Hospital, focusing on patients who are 18 years or older and can provide informed consent.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 undergoing primary total knee or hip arthroplasty at the University of Miami Hospital.
Not a fit: Patients with a history of sleep disorders, psychiatric conditions affecting sleep, or those taking sedative medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve sleep quality and pain management for patients recovering from joint replacement surgery.
How similar studies have performed: While there is limited data on Magnesium-L-Threonate specifically for sleep post-surgery, similar studies on magnesium supplementation have shown potential benefits in sleep quality.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Miami, Florida
- University of Miami Hospital — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Victor H Hernandez, MD — University of Miami
- Study coordinator: Victor H Hernandez, MD
- Email: vhh1@miami.edu
- Phone: 305-689-5195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.