Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing
NCT ID: NCT07299851
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
100 participants
INTERVENTIONAL
2025-10-01
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CFA-based supplement group
Participants will orally consume the assigned product for at least 12 weeks. Intake will be initiated from the day of Baseline (Visit 0) after all study procedures being performed until the morning of the last visit (Visit 3).
Participants will take 2 sachets a day directly in their mouth.
CFA-based food supplement
oral gel containing cetilated fatty acids
Placebo group
Participants will orally consume the assigned product for at least 12 weeks. Intake will be initiated from the day of Baseline (Visit 0) after all study procedures being performed until the morning of the last visit (Visit 3).
Participants will take 2 sachets a day directly in their mouth.
Placebo
oral gel coloured and flavoured as the IP
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CFA-based food supplement
oral gel containing cetilated fatty acids
Placebo
oral gel coloured and flavoured as the IP
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Artialis
INDUSTRY
Pharmanutra S.p.a.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jan Van Meirhaeghe
Role: PRINCIPAL_INVESTIGATOR
Department of Orthopaedics and Traumatology Ghent University Hospital (UZ Gent), Belgium
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AZ Monica
Deurne, Antwerp, Belgium
Algemeen Ziekenhuis Herentals
Herentals, Antwerp, Belgium
Hôpital Erasme - Cliniques Universitaires de Bruxelles
Brussels, Brussels Capital, Belgium
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, Belgium
Universitair Ziekenhuis Gent
Ghent, Flanders, Belgium
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Wouter Peeters
Role: primary
Willem-Jan Vleugels
Role: primary
Marc Jayankura
Role: primary
Maike Reul
Role: primary
Jan Van Meirhaeghe
Role: primary
Ben Molenaers
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CETI ULTRA-BONE
Identifier Type: -
Identifier Source: org_study_id