Recruiting

Magnesium-L-Threonate

Sponsor:

University of Miami

Code:

NCT06902285

Conditions

Sleep

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Magnesium Threonate

Control

Study Details

Brief 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

Conditions

Sleep

Knee Osteoarthritis

Study ID

NCT06902285

Start date

Apr 21, 2025

Status verified date

Jul, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Magnesium L Threonate Group

Participants in this group will receive the Magnesium L Threonate intervention for up to 6 weeks postoperatively

placebo comparator: Control Group

Participants in this group will receive the placebo comparator for up to 6 weeks postoperatively

Interventions

Magnesium Threonate

Participants will receive a daily 145 mg pill by mouth 30 minutes before going to sleep

Control

Participants will receive two sugar pills daily by mouth 30 minutes before going to sleep

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Victor H Hernandez, MD

305-689-5195vhh1@miami.edu

Jonathan Stern, MD

305-689-5195jms188@miami.edu

Locations

University of Miami Hospital

Recruiting

Miami, Florida, United States, 33136

Principal Investigator:

Victor H Hernandez, MD

More Information

Sponsor

University of Miami

Last update posted

Jul 9, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-07-09.