Randomized, Double-blind, Placebo-controlled Study of 12 Weeks Oral Cetylated Fatty Acids Supplementation to Support Early Healing of Long Lower Limb Bone Fractures After Surgical Stabilization

What this Trial Is About

Researchers are evaluating the potential benefits of an oral formulation based on Cetylated Fatty Acids in helping heal fractures of long bones in the lower limbs, such as the femur or tibia. This clinical trial is randomized, double-blind, and placebo-controlled, aiming to support the early stage of bone healing after surgical stabilization of these fractures. The study is sponsored by Pharmanutra S.p.a. and involves adults aged 18 to 85 years. Participants will take two sachets of the assigned oral product daily for at least 12 weeks, starting from the baseline visit after all initial procedures are completed. There are two study groups: one receiving the CFA-based food supplement and the other receiving a placebo gel matched in color and flavor. The intake continues until the morning of the last study visit (Visit 3). Throughout the study, participants will undergo standard imaging tests like radiography and ultrasound to assess bone healing. Blood samples will be collected, and participants will complete quality of life questionnaires such as the Short Form-36. Researchers will measure callus formation using the modified Radiographic Union Score for Tibia (mRUST) and monitor pain levels, complications, medication use, and participant satisfaction at 4, 6, and 12 weeks after fracture stabilization. Adherence to the supplement and any adverse events will also be tracked during the trial.

Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing