Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorPharmanutra S.p.a.
About this trial
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
Qualifiers
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
Disqualifiers
Treatment with vitamin D for medical purpose (Non-union, osteoporosis…)
BMI > 30
Open fracture
Intra articular fracture
Trial design
Treatments tested in this trial
- CFA-based food supplement
- Placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Pharmanutra S.p.a.
Lead sponsor
Artialis
Collaborator
Source ClinicalTrials.gov