NCT02999022

Brief Summary

This is a study designed to see if a low dose of Lithium treatment, taken for 2 weeks, can improve fracture healing and improve patients' function and productivity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2017

Longer than P75 for phase_2

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

July 21, 2017

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

January 26, 2024

Status Verified

January 1, 2024

Enrollment Period

7.4 years

First QC Date

September 9, 2016

Last Update Submit

January 25, 2024

Conditions

Fractures

Keywords

bone fracturesbony callusfractures, bonelithiumlithium carbonateosteogenesisbone developmentfracture healingfracture repair

Outcome Measures

Primary Outcomes (1)

  • radiographic healing of fracture

    radiographic healing using the RUST score at 8 weeks

    8 weeks after injury (non-surgical participants) or 8 weeks after surgery (surgical participants)

Secondary Outcomes (6)

  • radiographic union of fracture

    4, 6, 12, and 24 weeks after injury (non-surgical participants) or 4, 6, 12, and 24 weeks after surgery (surgical participants)

  • visual analogue pain score

    baseline then 4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or baseline then 4, 6, 8, 12, and 24 weeks after surgery (surgical participants)

  • physical function

    baseline then 4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or baseline then 4, 6, 8, 12, and 24 weeks after surgery (surgical participants)

  • NSAID use

    baseline then 3, 4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or baseline then 3, 4, 6, 8, 12, and 24 weeks after surgery (surgical participants)

  • re-operation (after initial fracture management)

    4, 6, 8, 12, and 24 weeks after injury (non-surgical participants) or 4, 6, 8, 12, and 24 weeks after surgery (surgical participants)

  • +1 more secondary outcomes

Study Arms (2)

Lithium carbonate

EXPERIMENTAL

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

Drug: Lithium Carbonate

Lactose placebo

PLACEBO COMPARATOR

Lactose placebo capsule; once per day for 2 weeks.

Drug: Lactose Placebo

Interventions

Lithium CarbonateDRUG

Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures.

Also known as: Lithium
Lithium carbonate
Lactose PlaceboDRUG

Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures.

Also known as: placebo
Lactose placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-55 years.
  • ASA (American Society of Anesthesiologists) ≤ 2 class (healthy) prior to injury.
  • Diaphyseal fracture of the humerus, femur or combined tibia/fibula (OTA diaphyseal subclass 2A or B), and clavicle (OTA diaphyseal subclass B1 or B2), with or without nerve injury.
  • Fracture that is primarily closed or open fracture that has complete wound coverage.
  • Randomization ≤14 days from injury or surgery (for surgical patients).
  • Fractures treated surgically or nonsurgically by endochondral/secondary bone healing.
  • For surgical patients, surgery must be within 14 days of injury.

You may not qualify if:

  • Currently pregnant or breastfeeding.
  • Any past or current malignancy that, in the opinion of an investigator, is not medically controlled.
  • Metabolic bone disease based on clinical history that, in the opinion of an investigator, is not medically controlled.
  • Autoimmune disease that, in the opinion of an investigator, is not medically controlled.
  • Hypothyroidism based on clinical history that, in the opinion of an investigator, is not medically controlled.
  • Renal impairment based on clinical history.
  • Past allergy or adverse reaction to Lithium.
  • Lactose intolerance.
  • Fractures surgically treated with absolute stability/primary bone healing.
  • Isolated tibia or isolated fibula fracture.
  • Currently taking Lithium or anti-psychotic or anti-seizure medication for the treatment of these conditions or at the discretion of an investigator.
  • Inability to comply with study protocol, in the opinion of the investigator(s).
  • Participation in another interventional clinical trial, at the discretion of the principal investigator.
  • Use of concomitant ultrasound or other bone stimulation device.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

RECRUITING

Hamilton Health Sciences

Hamilton, Ontario, Canada

RECRUITING

The Ottawa Hospital Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M5R 3P6, Canada

RECRUITING

Unity Health St. Michael's Hospital

Toronto, Ontario, Canada

RECRUITING

Related Publications (1)

  • Nam D, Balasuberamaniam P, Milner K, Kunz M, Vachhani K, Kiss A, Whyne C. Lithium for Fracture Treatment (LiFT): a double-blind randomised control trial protocol. BMJ Open. 2020 Jan 7;10(1):e031545. doi: 10.1136/bmjopen-2019-031545.

    PMID: 31915160DERIVED

MeSH Terms

Conditions

Fractures, BoneCallosities

Interventions

Lithium CarbonateLithium

Condition Hierarchy (Ancestors)

Wounds and InjuriesKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

CarbonatesAlkaliesInorganic ChemicalsCarbonic AcidCarbon Compounds, InorganicLithium CompoundsMetals, AlkaliElementsMetals, LightMetals

Study Officials

  • Diane Nam, MSc,MD,FRCSC

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pujitha Rao

CONTACT

416-480-5627lift@sunnybrook.ca

Mariam Saleem

CONTACT

Mariam.saleem@sunnybrook.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2016

First Posted

December 21, 2016

Study Start

July 21, 2017

Primary Completion

December 1, 2024

Study Completion

June 1, 2025

Last Updated

January 26, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(5)