Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty
Part of paid clinical trials in Miami, Florida.
- Sponsor
- University of Miami
- Study ID
- NCT06902285
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- Knee Osteoarthritis
- Sleep
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Magnesium Threonate — DRUGParticipants will receive a daily 145 mg pill by mouth 30 minutes before going to sleep
- Control — OTHERParticipants will receive two sugar pills daily by mouth 30 minutes before going to sleep
Study Details
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
Key Dates
- Start date
- Apr 21, 2025
- Status verified
- Apr 2026
- Primary completion
- Jul 1, 2026
- Completion
- Jul 1, 2026
Study Design
- Enrollment
- 64 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Magnesium L Threonate GroupParticipants in this group will receive the Magnesium L Threonate intervention for up to 6 weeks postoperatively
- Placebo Comparator: Control GroupParticipants in this group will receive the placebo comparator for up to 6 weeks postoperatively
Primary Outcome Measure
Change in Epsworth Sleepiness Score [ Time Frame: 2 weeks, 4 weeks, 6 weeks ]
Central Contacts
- Victor H Hernandez, MD305-689-5195
- Jonathan Stern, MD305-689-5195
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Miami Hospital | Miami | Florida | 33136 | Natalia Cruz, MD Jonathan Stern, MD (SUB_INVESTIGATOR) Natalia Cruz, MD (SUB_INVESTIGATOR) Victor H Hernandez, MD (PRINCIPAL_INVESTIGATOR) Colin McNamara, MD (SUB_INVESTIGATOR) |
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