NCT07299851

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

Randomized, Double-blind, Placebo-controlled Study With 12 Weeks Oral Supplementation With a Formulation Based on Cetylated Fatty Acids to Support the Early Stage of Long Lower Limb Bone Healing After Fracture Stabilization

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Pharmanutra S.p.a. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fracture Femur
• Fracture Tibia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	CFA-based food supplement	oral gel containing cetilated fatty acids
OTHER	Placebo	oral gel coloured and flavoured as the IP

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-05-01
• Completion: 2026-06-01
• First posted: 2025-12-23
• Last updated: 2025-12-23

Locations

6 sites across 1 country: Belgium