Recruiting NCT06902285
Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnesium Threonate, Control.
- Who it may be relevant to
- Registry conditions: Sleep, Knee Osteoarthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Use of Magnesium-L-Threonate to Improve Subjective Sleep Quality After Total Joint Arthroplasties: Randomized Controlled Clinical Trial
Overview
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
Interventions
- Drug Magnesium Threonate
Participants will receive a daily 145 mg pill by mouth 30 minutes before going to sleep - Other Control
Participants will receive two sugar pills daily by mouth 30 minutes before going to sleep
Primary outcome measures
- Change in Epsworth Sleepiness Score [Time frame: 2 weeks, 4 weeks, 6 weeks]
- Change in Pittsburgh Sleep Quality Index (PSQI) [Time frame: 2 weeks, 4 weeks, 6 weeks]
Secondary outcome measures (3)
- Change in Morphine Milligram Equivalent Prescribed [Time frame: 2 weeks, 4 weeks, 6 weeks]
- Patient-reported outcome measured by Knee Injury and Osteoarthritis Outcome Score [Time frame: 6 weeks]
- Medication Compliance measured in number of days study medication taken [Time frame: 6 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Miami Hospital — Miami
Identifiers
NCT: NCT06902285 · 20240578