Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing

NCT07299851 | Recruiting

• 1 other identifier: CETI ULTRA-BONE
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Fracture Femur; Fracture Tibia

Outcome Measures

Primary Outcomes (1)

• Radiographic Assessment of Callus Formation using the modified Radiographic Union Score for Tibia (mRUST).

  Comparison between groups of radiographic assessment of the callus formation using mRUST 6 weeks after fracture stabilisation. The mRUST scale ranges from 4 to 16 points, where higher scores indicate better fracture healing (greater callus formation and union).

  6 weeks after fracture stabilization

Secondary Outcomes (14)

• Pain Assessment at Fracture Site using the Visual Analog Scale (VAS)

  4 weeks after fracture stabilization

• Ultrasonographic Assessment of Callus Formation

  4 weeks after fracture stabilization

• Radiographic Assessment of Callus Formation (modified Radiographic Union Score for Tibia - mRUST)

  12 weeks after fracture stabilization

• Pain Assessment at Fracture Site (Visual Analog Scale - VAS)

  12 weeks after fracture stabilization

• Incidence of Complications

  4 weeks and 12 weeks after fracture stabilization

Study Arms (2)

CFA-based supplement group

EXPERIMENTAL

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.

Dietary Supplement: CFA-based food supplement

Placebo group

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Placebo OTHER

oral gel coloured and flavoured as the IP

Placebo group

CFA-based food supplement DIETARY_SUPPLEMENT

oral gel containing cetilated fatty acids

CFA-based supplement group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Pharmanutra S.p.a.: lead
• Artialis: collaborator

Study Sites (6)

AZ Monica

Deurne, Antwerp, 2100, Belgium

RECRUITING

Algemeen Ziekenhuis Herentals

Herentals, Antwerp, 2200, Belgium

RECRUITING

Hôpital Erasme - Cliniques Universitaires de Bruxelles

Brussels, Brussels Capital, 1070, Belgium

RECRUITING

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, Flanders, 9000, Belgium

RECRUITING

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

MeSH Terms

Conditions

Femoral Fractures; Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Jan Van Meirhaeghe

  Department of Orthopaedics and Traumatology Ghent University Hospital (UZ Gent), Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Sole Rossato

CONTACT

+390507846500; ms.rossato@pharmanutra.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 23, 2025
• Study Start: October 1, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BE (6)