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
Pharmanutra S.p.a.
100 participants
Oct 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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 Criteria23
- 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 severe vascular compromise across the fracture site (such as compartment syndrome, presence of serious vascular damage, etc.)
- Pathological fracture or diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope)
- Participants with known bone disease which would negatively impact on the bone healing process
- Participants currently being treated with radiation, chemotherapy, immunosuppression, or steroid therapy
- Diabetic participants
- Daily smoker participants (cigarette or vaping containing nicotine)
- Participants under cortisone intake
- Participants under rheumatic medications intake
- Allergy or adverse effect of food supplement composition
- Unwilling or unable to take study medication
- Chronic drug or alcohol abuse
- Pregnant or breastfeeding at the time of enrolment
- Any other investigational treatment or food supplement within 3 months.
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Interventions
oral gel containing cetilated fatty acids
oral gel coloured and flavoured as the IP
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07299851