Trials Today

Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty

Purpose

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

Conditions

Sleep
Knee Osteoarthritis

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: Phase 4
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Magnesium L Threonate Group	Participants in this group will receive the Magnesium L Threonate intervention for up to 6 weeks postoperatively	Drug: Magnesium Threonate Participants will receive a daily 145 mg pill by mouth 30 minutes before going to sleep
Placebo Comparator Control Group	Participants in this group will receive the placebo comparator for up to 6 weeks postoperatively	Other: Control Participants will receive two sugar pills daily by mouth 30 minutes before going to sleep

Recruiting Locations

University of Miami Hospital
Miami, Florida 33136

Contact:
Natalia Cruz, MD

More Details

NCT ID: NCT06902285
Status: Recruiting
Sponsor: University of Miami

Study Contact

Victor H Hernandez, MD
305-689-5195
vhh1@miami.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.