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Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
Sponsor: Pharmanutra S.p.a.
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2025-10-01
Completion Date
2026-06
Last Updated
2025-12-23
Healthy Volunteers
No
Conditions
Interventions
CFA-based food supplement
oral gel containing cetilated fatty acids
Placebo
oral gel coloured and flavoured as the IP
Locations (6)
AZ Monica
Deurne, Antwerp, Belgium
Algemeen Ziekenhuis Herentals
Herentals, Antwerp, Belgium
Hôpital Erasme - Cliniques Universitaires de Bruxelles
Brussels, Brussels Capital, Belgium
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, Belgium
Universitair Ziekenhuis Gent
Ghent, Flanders, Belgium
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium