Actively Recruiting
Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
Led by Pharmanutra S.p.a. · Updated on 2025-12-23
100
Participants Needed
6
Research Sites
34 weeks
Total Duration
On this page
Sponsors
P
Pharmanutra S.p.a.
Lead Sponsor
A
Artialis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 85 years old
- Simple closed unifocal fracture (transverse, oblique, spiral, butterfly-shaped) in a long bone requiring standard surgical stabilization
- Diaphyseal fracture of lower limb (femur or tibia, including subtrochanteric fractures)
- Presence of an intramedullary nail
- Weight bearing as tolerated after surgery
- Signed informed consent, understands and can follow study procedures
- Agreed to stop vitamin D intake if taking prophylactic vitamin D
You will not qualify if you...
- Treatment with vitamin D for medical purposes (e.g., non-union, osteoporosis)
- Body mass index (BMI) greater than 30
- Open fracture
- Intra-articular fracture
- Metaphyseal fracture
- Polytrauma with injury severity score (ISS) 16 or higher
- More than one lower limb long bone fractured
- Use of bridging plate
- Fracture treated conservatively with plaster
- Active infection (body temperature 38°C or higher or other symptoms)
- Severe vascular compromise near fracture (e.g., compartment syndrome, major vascular damage)
- Pathological fracture or diseases causing recurrent falling (e.g., Parkinson's, hemiplegia after stroke, spinal stenosis, polyneuropathy, epilepsy, vertigo, syncope)
- Known bone diseases affecting healing
- Current treatment with radiation, chemotherapy, immunosuppression, or steroids
- Diabetes
- Daily smoker (cigarettes or vaping with nicotine)
- Taking cortisone or rheumatic medications
- Allergy or adverse reaction to supplement components
- Unwilling or unable to take study medication
- Chronic drug or alcohol abuse
- Pregnant or breastfeeding at enrollment
- Use of other investigational treatments or supplements within past 3 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
AZ Monica
Deurne, Antwerp, Belgium, 2100
Actively Recruiting
2
Algemeen Ziekenhuis Herentals
Herentals, Antwerp, Belgium, 2200
Actively Recruiting
3
Hôpital Erasme - Cliniques Universitaires de Bruxelles
Brussels, Brussels Capital, Belgium, 1070
Actively Recruiting
4
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, Belgium, 1090
Actively Recruiting
5
Universitair Ziekenhuis Gent
Ghent, Flanders, Belgium, 9000
Actively Recruiting
6
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium, 3600
Actively Recruiting
Research Team
M
Maria Sole Rossato
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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