Magnesium Threonate for Sleep After Joint Replacement

Overseen By Jonathan Stern, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Miami

Must not be taking: Sedatives, Insomnia medications

Disqualifiers: Sleeping disorders, Psychiatric disorders, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

64 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Magnesium-L-Threonate, a dietary supplement, can improve sleep and reduce pain after total knee or hip replacement surgery. Researchers will divide participants into two groups: one receiving Magnesium-L-Threonate and the other a placebo, a harmless pill with no active effects. This study targets English or Spanish-speaking patients undergoing their first knee or hip replacement surgery, without a history of sleep disorders or certain other medical conditions. Those experiencing sleep difficulties after surgery may find this trial relevant. As a Phase 4 trial, it involves an FDA-approved treatment, seeking to understand its benefits for a broader patient population.

Will I have to stop taking my current medications?

The trial excludes participants who are taking medications known to cause significant sedation or insomnia, so you may need to stop those specific medications. The protocol does not specify other medication restrictions.

What is the safety track record for Magnesium-L-Threonate?

Research has shown that Magnesium-L-Threonate (MgT) is safe for use. Studies have found that individuals taking MgT reported improved sleep, particularly in the deep and REM (rapid eye movement) stages, which are crucial for feeling rested. Most participants did not experience serious side effects. MgT also improved mood and energy levels, enhancing its positive safety profile. Based on past research, MgT appears to be a safe option for improving sleep. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard care options for sleep issues after joint replacement, which often involve sedatives or pain relievers, Magnesium-L-Threonate offers a unique approach by using a specific type of magnesium that can cross the blood-brain barrier more effectively. This means that it has the potential to directly influence brain function and improve sleep quality more naturally. Researchers are excited about this treatment because it targets the root of sleep disturbances without the side effects commonly associated with traditional sleep medications.

What evidence suggests that Magnesium-L-Threonate might be an effective treatment for sleep after joint replacement?

Research has shown that Magnesium-L-Threonate (MgT) can enhance sleep quality, particularly in the deep and REM sleep stages. This improvement may help individuals sleep better and wake up more refreshed. Studies have also found that MgT can boost mood, energy, and alertness during the day, leading to better daily activity and productivity. In this trial, participants in the Magnesium L-Threonate Group will receive MgT, while those in the Control Group will receive a placebo comparator. A study comparing MgT to a placebo found that those taking MgT experienced better sleep and daytime functioning. This suggests that MgT could aid in improving sleep and recovery after joint replacement surgery. ^{2 4 5 6 7}

Who Is on the Research Team?

Victor H Hernandez, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone total joint replacement surgery due to osteoarthritis and are experiencing sleep disturbances. Participants should be interested in seeing if Magnesium-L-Threonate can help improve their sleep quality and reduce pain post-surgery.

Inclusion Criteria

I am having a knee or hip replacement at the University of Miami Hospital.

I am over 18 years old.

I am able to understand and agree to the study's procedures and risks.

Exclusion Criteria

Patients with known substance use disorder within 6 months of surgery

I have a history of sleep disorders such as narcolepsy or insomnia.

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Magnesium L Threonate or placebo for up to 6 weeks postoperatively

6 weeks

Follow-up

Participants are monitored for changes in sleep quality and pain management after treatment

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Magnesium-L-Threonate

Trial Overview The study is testing the effectiveness of Magnesium-L-Threonate (MgT) on improving sleep quality and reducing pain after joint replacement surgery, compared to a control group not receiving MgT.

How Is the Trial Designed?

Group I: Magnesium L Threonate Group Experimental Treatment 1 Intervention

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

Group II: Control Group Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06902285/magnesium-l-threonate-for-sleep-quality-post-arthroplasty

Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty The study team is conducting a study to see if Magnesium-L-Threonate (MgT) can help improve how well participants sleep and reduce pain ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39252819/

Magnesium-L-threonate improves sleep quality and ... This showed MgT improved sleep quality, especially deep/REM sleep stages, improved mood, energy, alertness, and daily activity and productivity.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11381753/

Magnesium-L-threonate improves sleep quality and ... This showed MgT improved sleep quality, especially deep/REM sleep stages, improved mood, energy, alertness, and daily activity and productivity.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07015047

Effects of Magnesium L-Threonate on Sleep, Recovery ... Primary outcomes include objective changes in sleep stages and HRV. Secondary outcomes include changes in physical performance and subjective recovery. This ...

5. ajmc.com ajmc.com/view/study-magnesium-l-threonate-improves-objective-subjective-sleep-quality

Study: Magnesium-L-Threonate Improves Objective, ... A new form of magnesium supplement appears to lead to superior sleep and improved daytime functioning, according to a new placebo-controlled study.

6. trials.arthritis.org trials.arthritis.org/trials/NCT06902285

Magnesium-L-Threonate for Sleep Quality Post-Arthroplasty ... sleep and reduce pain after total joint replacement surgery. Recruitment ... safety data. Phase 3: Studies that gather more information about safety and ...

7. nutraceuticalsworld.com nutraceuticalsworld.com/breaking-news/magnesium-l-threonate-improves-sleep-quality-clinical-study/

Magnesium L-Threonate Improves Sleep Quality: Clinical ... Magnesium L-threonate was safe and well tolerated. “This study confirms numerous consumers' reviews indicating restorative sleep when taking ...