Clinical Trial Finder

Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06902285
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Miami
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Victor H Hernandez, MD
Principal Investigator Affiliation University of Miami
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Sleep, Knee Osteoarthritis
Arms & Interventions

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Miami Hospital, Miami, Florida

Status

Address

University of Miami Hospital

Miami, Florida, 33136

Site Contact

Natalia Cruz, MD

[email protected]

305-689-5195

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