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

Trial Summary

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 data supports the effectiveness of the drug Magnesium-L-Threonate for improving sleep after joint replacement?

Research suggests that magnesium, in general, may be linked to better sleep quality, as seen in studies where higher magnesium intake was associated with reduced daytime sleepiness and improved sleep patterns. However, the specific effects of Magnesium-L-Threonate on sleep after joint replacement are not directly studied, and more research is needed to confirm its effectiveness for this purpose. ^{1 2 3 4 5}

Is Magnesium-L-Threonate safe for humans?

Magnesium-L-Threonate has been studied for its effects on pain relief and reducing opioid use in advanced cancer patients, and no serious safety concerns were reported. Other forms of magnesium, like magnesium sulfate, have been used in various surgeries without serious adverse effects in adults. ^{2 3 5 6 7}

How does the drug Magnesium-L-Threonate differ from other treatments for sleep issues after joint replacement?

Magnesium-L-Threonate is unique because it is specifically designed to increase magnesium levels in the brain, which can help regulate sleep by enhancing neurotransmitter activity and brain wave patterns. Unlike other magnesium supplements, it has higher bioavailability, meaning it is more effectively absorbed by the body, potentially offering better support for sleep quality. ^{1 4 8 9 10}

What is the purpose of this trial?

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

Research Team

Victor H Hernandez, MD

Principal Investigator

University of Miami

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

The Role of Magnesium in Sleep Health: a Systematic Review of Available Literature. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Oral application of magnesium-L-threonate enhances analgesia and reduces the dosage of opioids needed in advanced cancer patients-A randomized, double-blind, placebo-controlled trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Magnesium sulphate attenuates acute postoperative pain and increased pain intensity after surgical injury in staged bilateral total knee arthroplasty: a randomized, double-blinded, placebo-controlled trial. [2018]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Magnesium Intake and Sleep Disorder Symptoms: Findings from the Jiangsu Nutrition Study of Chinese Adults at Five-Year Follow-Up. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Magnesium sulfate for postoperative complications in children undergoing tonsillectomies: a systematic review and meta-analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Intra-articular magnesium to alleviate postoperative pain after arthroscopic knee surgery: a meta-analysis of randomized controlled trials. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Oral magnesium lozenge reduces postoperative sore throat: a randomized, prospective, placebo-controlled study. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of a magnesium-deficient diet on sleep organization in rats. [2017]

9. Switzerland pubmed.ncbi.nlm.nih.gov

A Novel Theanine Complex, Mg-L-Theanine Improves Sleep Quality via Regulating Brain Electrochemical Activity. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

A Magtein®, Magnesium L-Threonate, -Based Formula Improves Brain Cognitive Functions in Healthy Chinese Adults. [2022]