Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty

NCT ID: NCT06902285

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-21
• Study Completion Date: 2026-05-01

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Magnesium L Threonate Group

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

Group Type: EXPERIMENTAL

Magnesium Threonate

Intervention Type: DRUG

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

Control Group

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

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

Magnesium Threonate

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

Intervention Type: DRUG

Control

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Victor Hugo Hernandez

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victor H Hernandez, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Hospital

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Victor H Hernandez, MD

Role: CONTACT

vhh1@miami.edu

305-689-5195

Jonathan Stern, MD

Role: CONTACT

jms188@miami.edu

305-689-5195

Facility Contacts

Natalia Cruz, MD

Role: primary

Other Identifiers

20240578

Identifier Type: -

Identifier Source: org_study_id