Oral cetylated fatty acid supplement to improve healing after femur or tibia shaft fracture
Official title: 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
Run by Pharmanutra S.p.a. · NCT07299851 · Data updated 2026-11-12
This trial will test whether taking an oral cetylated fatty acid supplement for 12 weeks helps adults with surgically fixed femur or tibia shaft fractures heal faster or regain better function than a placebo.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Pharmanutra S.p.a. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 6 sites (Deurne, Antwerp and 5 other locations) |
| Status | Recruiting |
| Started | October 1, 2025 |
| Main results expected | May 2026 |
| Study ends | June 2026 |
| Registry record updated | December 23, 2025 |
| Trial ID | NCT07299851 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults 18–85 with a closed, single diaphyseal femur or tibia fracture fixed with an intramedullary nail who can bear weight as tolerated and comply with 12 weeks of follow-up.
✕Probably not a fit
Patients with open, intra-articular, metaphyseal, multiple or conservatively treated fractures, active infection, BMI >30, ongoing vitamin D treatment for medical reasons, or polytrauma are unlikely to match the trial profile and may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults aged 18–85 with a closed, unifocal diaphyseal fracture of the femur or tibia treated with an intramedullary nail receive either a cetylated fatty acid (CFA) oral supplement or a matching placebo for 12 weeks alongside standard postoperative care. Study procedures include standard radiography and ultrasonography, blood sampling, and validated quality-of-life questionnaires to monitor radiographic and clinical healing. Key exclusion criteria are open, intra-articular or metaphyseal fractures, BMI >30, polytrauma, ongoing therapeutic vitamin D use, active infection, or non-surgical fracture management. The trial is sponsored by Pharmanutra and conducted at three Belgian hospital sites.
Why it matters
Potential benefit: If effective, the supplement could speed radiographic and functional recovery after lower-limb shaft fractures, potentially reducing pain and time to return to normal activities.
How similar studies have gone: Use of cetylated fatty acids for fracture healing is largely novel with limited clinical evidence, while most prior CFA work has focused on topical joint symptom relief or preclinical bone models.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 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's running
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AZ Monica
Deurne, Antwerp, Belgium Recruiting -
Algemeen Ziekenhuis Herentals
Herentals, Antwerp, Belgium Recruiting -
Hôpital Erasme - Cliniques Universitaires de Bruxelles
Brussels, Brussels Capital, Belgium Recruiting -
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, Belgium Recruiting -
Universitair Ziekenhuis Gent
Ghent, Flanders, Belgium Recruiting -
Ziekenhuis Oost-Limburg
Genk, Limburg, Belgium Recruiting
Study contacts
- Principal investigator: Jan Van Meirhaeghe — Department of Orthopaedics and Traumatology Ghent University Hospital (UZ Gent), Belgium
- Study coordinator: Maria Sole Rossato
- Email: ms.rossato@pharmanutra.it
- Phone: +390507846500
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.