Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty

NCT06902285 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 20240578
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Morphine Milligram Equivalent Prescribed

  2 weeks, 4 weeks, 6 weeks

• Patient-reported outcome measured by Knee Injury and Osteoarthritis Outcome Score

  6 weeks

• Medication Compliance measured in number of days study medication taken

  6 weeks

Study Arms (2)

Magnesium L Threonate Group

EXPERIMENTAL

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

Drug: Magnesium Threonate

Control Group

PLACEBO COMPARATOR

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

Other: Control

Interventions

Magnesium Threonate DRUG

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

Magnesium L Threonate Group

Control OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Hospital

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

threonic acid

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Victor H Hernandez, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Victor H Hernandez, MD

CONTACT

305-689-5195; vhh1@miami.edu

Jonathan Stern, MD

CONTACT

305-689-5195; jms188@miami.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: April 21, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)