Lithium for Fracture Treatment: a Double Blind Randomized Controlled Trial

LiFT001

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.

2017-07-21

2024-12-01

2025-06-01

Recruiting

Early phase I

160

Inclusion Criteria: 1. Age 18-55 years. 2. ASA (American Society of Anesthesiologists) ≤ 2 class (healthy) prior to injury. 3. 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. 4. Fracture that is primarily closed or open fracture that has complete wound coverage. 5. Randomization ≤14 days from injury or surgery (for surgical patients). 6. Fractures treated surgically or nonsurgically by endochondral/secondary bone healing. 7. For surgical patients, surgery must be within 14 days of injury. Exclusion Criteria: 1. Currently pregnant or breastfeeding. 2. Any past or current malignancy that, in the opinion of an investigator, is not medically controlled. 3. Metabolic bone disease based on clinical history that, in the opinion of an investigator, is not medically controlled. 4. Autoimmune disease that, in the opinion of an investigator, is not medically controlled. 5. Hypothyroidism based on clinical history that, in the opinion of an investigator, is not medically controlled. 6. Renal impairment based on clinical history. 7. Past allergy or adverse reaction to Lithium. 8. Lactose intolerance. 9. Fractures surgically treated with absolute stability/primary bone healing. 10. Isolated tibia or isolated fibula fracture. 11. Currently taking Lithium or anti-psychotic or anti-seizure medication for the treatment of these conditions or at the discretion of an investigator. 12. Inability to comply with study protocol, in the opinion of the investigator(s). 13. Participation in another interventional clinical trial, at the discretion of the principal investigator. 14. Use of concomitant ultrasound or other bone stimulation device.

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2024-01-26