Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bon… (NCT07299851) | Clinical Trial Compass
RecruitingNot Applicable
Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
Belgium100 participantsStarted 2025-10-01
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 w…
What they're measuring
1
Radiographic Assessment of Callus Formation using the modified Radiographic Union Score for Tibia (mRUST).