Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Fracture Femur, Fracture Tibia
In brief
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.
Key facts
- Study ID
- NCT07299851
- Run by
- Pharmanutra S.p.a.
- People needed
- 100
- Starts
- 2025-10-01
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-12-23
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- AZ Monica — Deurne, Antwerp, Belgium (enrolling)
- Algemeen Ziekenhuis Herentals — Herentals, Antwerp, Belgium (enrolling)
- Hôpital Erasme - Cliniques Universitaires de Bruxelles — Brussels, Brussels Capital, Belgium (enrolling)
- Universitair Ziekenhuis Brussel — Brussels, Brussels Capital, Belgium (enrolling)
- Universitair Ziekenhuis Gent — Ghent, Flanders, Belgium (enrolling)
- Ziekenhuis Oost-Limburg — Genk, Limburg, Belgium (enrolling)
Full record on ClinicalTrials.gov
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