NCT07299851 Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
| NCT ID | NCT07299851 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pharmanutra S.p.a. |
| Condition | Fracture Femur |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-05 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This clinical study aims to evaluate the potential benefits of a formulation based on Cetylated Fatty Acids in improving fracture healing of long bones in the lower limbs. The investigational product is administered orally over a 12-week period. Study procedures are limited to standard imaging techniques (radiography and echography), blood sampling, and completion of validated quality of life questionnaires.
Eligibility Criteria
Inclusion Criteria: * Between 18 and 85 years old * Presence of simple closed unifocal fracture (transverse, oblique, spiral, butterfly-shaped) in a long bone which need a standard of care surgical stabilization * Presence of diaphyseal fracture of lower limb (femur or tibia, Subtrochanteric fracture are also allowed) * Presence intramedullary nail * Weight bearing as tolerated after surgery * Having signed an informed consent, understand study procedures and ability to follow them * Agreed to stop vitamin D intake for participants who take prophylactic Vitamin D Exclusion Criteria: * Treatment with vitamin D for medical purpose (Non-union, osteoporosis…) * BMI \> 30 * Open fracture * Intra articular fracture * Metaphyseal fracture * Polytrauma patient (injury severity score: ISS \>= 16) * More than one lower limb long bone fracture * Bridging plate * Fracture treated conservatively with plaster * Presence of active infection (body temperature ≥ 38°C or other symptoms) * Any sign of se