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

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

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis; Sleep
• Intervention / Treatment: Drug: Magnesium Threonate; Other: Control

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Victor H Hernandez, MD; Phone Number: 305-689-5195; Email: vhh1@miami.edu
• Study Contact Backup: Name: Jonathan Stern, MD; Phone Number: 305-689-5195; Email: jms188@miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami Hospital
      • Principal Investigator: Victor H Hernandez, MD
      • Sub-Investigator: Natalia Cruz, MD
      • Contact: Natalia Cruz, MD
      • Sub-Investigator: Jonathan Stern, MD
      • Sub-Investigator: Colin McNamara, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Epsworth Sleepiness Score	Score ranging from 0-24 with higher scores indicating greater sleepiness.	2 weeks, 4 weeks, 6 weeks
Change in Pittsburgh Sleep Quality Index (PSQI)	The total score has a value between 0-21 and a high total score demonstrates a poor quality of sleep. A total PSQI score which is ≤5 indicates "good sleep", and a score which is >5 indicates "poor sleep	2 weeks, 4 weeks, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Morphine Milligram Equivalent Prescribed	Measured in milligram equivalents	2 weeks, 4 weeks, 6 weeks
Patient-reported outcome measured by Knee Injury and Osteoarthritis Outcome Score	The total score ranges from 0-100. Lowers scores indicate a healthier knee	6 weeks
Medication Compliance measured in number of days study medication taken	Medication compliance as measured by number of days taking study medication	6 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Victor H Hernandez, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; threonic acid
• Other Study ID Numbers: 20240578

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No