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Mood Stabilizer

Lithium for Broken Bones (LiFT Trial)

Phase 2

Recruiting

Led By Diane Nam, MSc,MD,FRCSC

Research Sponsored by Sunnybrook Health Sciences Centre

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Fracture that is primarily closed or open fracture that has complete wound coverage

Age 18-55 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2-6 weeks after injury (non-surgical participants) or 2-6 weeks after surgery (surgical participants)

Awards & highlights

LiFT Trial Summary

This trial will test if a low dose of lithium can help improve healing from fractures and increase patients' function and productivity.

Who is the study for?

The LiFT trial is for healthy adults aged 18-55 with certain types of broken bones (humerus, femur, tibia/fibula, clavicle) that can heal on their own or after surgery. Participants must not have uncontrolled diseases like cancer or autoimmune disorders, be pregnant/breastfeeding, lactose intolerant, have renal issues or past bad reactions to Lithium.Check my eligibility

What is being tested?

This study tests if a low dose of Lithium Carbonate over two weeks helps bone fractures heal better compared to a Lactose Placebo. It's double-blind meaning neither the patients nor the researchers know who gets the real treatment versus placebo until after results are collected.See study design

What are the potential side effects?

While not specified here, common side effects of Lithium may include increased thirst and urination, nausea and general discomfort in the stomach area. More serious but less common side effects could involve changes in heart rhythm or thyroid function.

LiFT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My fracture is either fully closed or, if open, the wound is completely covered.

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I am between 18 and 55 years old.

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I was injured or had surgery less than 14 days ago.

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I have a mid-shaft fracture in my arm, leg, or collarbone, possibly with nerve damage.

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My surgery is scheduled within 14 days of my injury.

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I have had a fracture that was treated.

LiFT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2-6 weeks after injury (non-surgical participants) or 2-6 weeks after surgery (surgical participants)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2-6 weeks after injury (non-surgical participants) or 2-6 weeks after surgery (surgical participants)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-6 weeks after injury (non-surgical participants) or 2-6 weeks after surgery (surgical participants) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

radiographic healing of fracture

Secondary outcome measures

Anti-Inflammatory Agents, Non-Steroidal

adverse events

physical function

+3 more

LiFT Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Lithium carbonateExperimental Treatment1 Intervention

Lithium carbonate 300mg capsule; once per day for 2 weeks.

Group II: Lactose placeboPlacebo Group1 Intervention

Lactose placebo capsule; once per day for 2 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lithium Carbonate

2008

Completed Phase 4

~1280

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Sunnybrook Health Sciences CentreLead Sponsor

656 Previous Clinical Trials

1,551,282 Total Patients Enrolled

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,344 Previous Clinical Trials

26,453,257 Total Patients Enrolled

Diane Nam, MSc,MD,FRCSCPrincipal InvestigatorSunnybrook Health Sciences Centre

Media Library

Lithium Carbonate (Mood Stabilizer) Clinical Trial Eligibility Overview. Trial Name: NCT02999022 — Phase 2

Broken Bones Research Study Groups: Lithium carbonate, Lactose placebo

Broken Bones Clinical Trial 2023: Lithium Carbonate Highlights & Side Effects. Trial Name: NCT02999022 — Phase 2

Lithium Carbonate (Mood Stabilizer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02999022 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being accepted into this research initiative?

"Affirmative, the clinical trial is currently recruiting. According to data on clinicaltrials.gov, it was first advertised in July 2017 with its last update occurring in June 2022. 160 participants from 3 different sites are required for this experiment."

Answered by AI

Are there any opportunities to apply for this research endeavor?

"As documented on clinicaltrials.gov, this medical experiment is currently recruiting participants, having been initially published on July 21st 2017 and recently edited as of June 6th 2022."

Answered by AI

Has the Federal Drug Administration given approval to utilize Lithium Carbonate?

"The existing data on Lithium Carbonate's safety supports a score of 2, as this is currently in Phase 2 and there are no studies yet to confirm its efficacy."

Answered by AI